https://podcast.easymedicaldevice.comenSociety & CultureCopyright Monir El Azzouzihttps://d3wo5wojvuv7l.cloudfront.net/t_rss_itunes_square_1400/images.spreaker.com/original/092ac98ebb1fbccf0595e685f8581e5b.jpghttps://podcast.easymedicaldevice.comWed, 01 Mar 2023 19:22:26 +0000Monir El AzzouziMonir El Azzouziinfo@easymedicaldevice.comListen Medical Device Regulation and Standardscleanepisodichttps://www.spreaker.com/user/easymedicaldevice/prepare-your-transition-from-class-i-to-Prepare your transition from Class I to Class Ir appeared first on Medical Device made Easy Podcast. hamza benafqir]]>https://podcast.easymedicaldevice.com/?p=3157Tue, 28 Feb 2023 00:00:00 +0000Monir El AzzouziIn this episode, Tautvydas will share with us its experience with Manufacturers that tries to move from Class I to Class Ir for Reusable Surgical Instruments. Don't miss it if your company is on scope. The post...Prepare your transition from Class I to Class Ir appeared first on Medical Device made Easy Podcast. hamza benafqir]]>192713485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/samd-international-reach-what-to-consideSaMD international reach – What to consider?  appeared first on Medical Device made Easy Podcast. hamza benafqir]]>https://podcast.easymedicaldevice.com/?p=3142Tue, 21 Feb 2023 00:00:00 +0000Monir El AzzouziThe Global reach can be a problem when we talk about Medical Device. This is mainly what we will discuss with Stéphane Berger as he is trying to put globally is Software as a Medical Device in different markets. Let'S hear about the difficulty. The...SaMD international reach – What to consider?  appeared first on Medical Device made Easy Podcast. hamza benafqir]]>211113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/biological-evaluation-top-big-mistakesBiological Evaluation: Top Big mistakes appeared first on Medical Device made Easy Podcast. hamza benafqir]]>https://podcast.easymedicaldevice.com/?p=3124Tue, 14 Feb 2023 00:00:00 +0000Monir El AzzouziIf you need to perform a Biological Evaluation for your Medical Device, Paul and Laura from Icare Group will be the best partners for you. Check the advice they provide. The post https://podcast.easymedicaldevice.com/219-2/ appeared first on...Biological Evaluation: Top Big mistakes appeared first on Medical Device made Easy Podcast. hamza benafqir]]>325113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-february-2023-regulaMedical Device News: February 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3109Mon, 06 Feb 2023 23:46:01 +0000Monir El AzzouziYour Medical Device News is ready for the month of February 2023. This is containing some information on the extension of the EU MDR timeline so don't miss it. The post https://podcast.easymedicaldevice.com/218-2/ appeared first on...Medical Device News: February 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>155213485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-do-post-marketing-surveillance-inHow to do Post-Marketing Surveillance in the US (vs EU)? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3101Tue, 31 Jan 2023 00:31:00 +0000Monir El AzzouziPost marketing Surveillance for medical devices in the US market is done differently than in EU. So learn on this podcast how to be prepared with Rob Packard. We will talk about multiple sort of devices and how FDA is handling the way to do Post...How to do Post-Marketing Surveillance in the US (vs EU)? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>309013485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-evaluate-benefit-risk-ratio-for-mHow to evaluate Benefit-Risk Ratio for Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3092Tue, 24 Jan 2023 01:00:00 +0000Monir El AzzouziYou maybe arrived to this section of the Techniocal File asking for Risk Benefit Ratio and you don't know what to write on it. On this episode we will explain to you what are your possibilities and how you should thing about Risk-Benefit ratio with...How to evaluate Benefit-Risk Ratio for Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>264313485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/breaking-news-eu-mdr-extension-proposal-Breaking News: EU MDR Extension Proposal is out for consultation appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3083Tue, 17 Jan 2023 01:00:00 +0000Monir El AzzouziYou asked for the extension of the transition period for MDR? Then you have the proposal for the change. Now the question is if you are satisfied and if the content is helping you? No worry if you don't like it they are expecting your immediate...Breaking News: EU MDR Extension Proposal is out for consultation appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>236113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-improve-the-relationship-between-How to improve the relationship between QA – RA and Marketing? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3072Tue, 10 Jan 2023 00:00:00 +0000Monir El AzzouziLet's see if you can improve relationship between your industry departments and Quality and Regulatory affairs. We will talk about that with Omar M. Khateeb who will explain to us how Marketing and QA RA should work together. The post...How to improve the relationship between QA – RA and Marketing? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>253913485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-january-2023-regulatMedical Device News: January 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3065Tue, 03 Jan 2023 07:46:43 +0000Monir El AzzouziAll your Medical Device Regulatory update for January 2023 within 30 minutes. Listen to this podcast episode with Monir El Azzouzi The post https://podcast.easymedicaldevice.com/213-2/ appeared first on https://podcast.easymedicaldevice.com....Medical Device News: January 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>176813485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/grow-your-linkedin-profile-with-karandeeGrow your LinkedIn Profile with Karandeep Badwal appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3054Tue, 27 Dec 2022 02:30:00 +0000Monir El AzzouziIf you are looking to grow your LinkedIn profile then you should listen to this episode where Karandeep Badwal will give his learning being part of the LinkedIn Creator Accelerator Program. The post https://podcast.easymedicaldevice.com/212-2/...Grow your LinkedIn Profile with Karandeep Badwal appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>271913485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/is-eu-mdr-extended-with-erik-vollebregtIs EU MDR extended? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3046Tue, 20 Dec 2022 00:50:00 +0000Monir El AzzouziI know you all heard about the extension of transition period for the EU MDR 2017/745. This is a good news, but let'S understand what this means and how you should interpret all this as there are some misinformation that are spread and we will try to...Is EU MDR extended? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>310213485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/mdcg-team-nb-bvmed-team-prrc-tell-you-alMDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3031Tue, 13 Dec 2022 01:00:00 +0000Monir El AzzouziIf you have a question about the role of a PRRC then most likely this will be answered by one of those expert. This podcast will display the Team-PRRC event where EU commission, Team-NB and BVMed answered the questions of Bassil Akra Board member of...MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>237513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-december-2022-regulaMedical Device News – December 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3019Tue, 06 Dec 2022 07:29:58 +0000Monir El AzzouziAll the latest regulatory news for the Medical Device Industry in 30 minutes The post https://podcast.easymedicaldevice.com/209-2/ appeared first on https://podcast.easymedicaldevice.com. https://podcast.easymedicaldevice.com/author/melazzouzi/Medical Device News – December 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>200213485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-choose-the-best-sterilization-metHow to choose the best Sterilization Method for Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3007Tue, 29 Nov 2022 00:00:00 +0000Monir El AzzouziThis is a questions that I get asked when I am part of the design process of medical devices. Which Sterilization method should we choose? I invited Jane Scally to help us define the best practices when it comes to the Sterilization process. The post...How to choose the best Sterilization Method for Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>236513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/why-risk-management-is-important-to-mediWhy Risk Management is important to Medical Device development? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=3001Tue, 22 Nov 2022 00:00:00 +0000Monir El AzzouziWhy is Risk Management so important? This is maybe something that a lot of regulators are asking you. "Do you have your Risk Management?" In this episode, we will explain to you why this is most critical information to get. The post...Why Risk Management is important to Medical Device development? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>125313485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/regulatory-pathway-how-to-reach-the-us-mRegulatory Pathway: How to reach the US market? [510k exempt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2990Tue, 15 Nov 2022 00:00:00 +0000Monir El AzzouziIf you are willing to reach out to the US there may be multiple strategies. We will talk today about MysteryVibe that started to evaluate the market and identified that their product is class IIa in EU and Class II in the US. But in the US this is...Regulatory Pathway: How to reach the US market? [510k exempt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>203113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/your-software-ivd-clinical-report-is-comYour Software/IVD clinical report is completely WRONG! appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2966Tue, 08 Nov 2022 00:00:00 +0000Monir El AzzouziIf you are in the Software and IVD industry we would bet that you are making your clinical data gathering wrong. Cesare Magri will explain to you why and how to correct that. So listen carefully to his advise. The post...Your Software/IVD clinical report is completely WRONG! appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>157313485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-november-2022-regulaMedical Device News – November 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2969Tue, 01 Nov 2022 01:00:00 +0000Monir El AzzouziWhat happened to the Medical Device industry? Let's learn in this episode with Monir El Azzouzi The post https://podcast.easymedicaldevice.com/204/ appeared first on https://podcast.easymedicaldevice.com....Medical Device News – November 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>189513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/can-you-go-to-jail-as-a-prrc-elem-ayneCan you go to Jail as a PRRC? [Elem Ayne] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2958Tue, 25 Oct 2022 01:00:00 +0000Monir El AzzouziYou are maybe asked to become a PRRC and you start to have a lot of questions. I am sure these are the questions that you ask yourself as this is also what other people are willing to know. They contacted Elem Ayne at Team PRRC and the association is...Can you go to Jail as a PRRC? [Elem Ayne] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>175413485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-be-mdsap-certified-for-your-medicHow to be MDSAP certified for your Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2939Tue, 18 Oct 2022 01:00:00 +0000Monir El AzzouziMDSAP is now in place since few years. For those that still have no understanding of it, I will tell you all on it from who needs it to how to be prepared for it. Enjoy! The post https://podcast.easymedicaldevice.com/202-2/ appeared first on...How to be MDSAP certified for your Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>177213485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/what-do-clients-followers-team-think-of-What do Clients, Followers, Team, … think of Easy Medical Device? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2919Tue, 04 Oct 2022 00:00:00 +0000Monir El AzzouziThis is the celebration episode for the 200th consecutive week where we released the podcast. This time I asked some of the stakeholders to provide a feedback about their experience with Easy Medical Device and the Podcast. The post...What do Clients, Followers, Team, … think of Easy Medical Device? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>245013485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-select-your-notified-body-and-undHow to select your Notified Body and understand the full process? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2909Tue, 27 Sep 2022 00:00:00 +0000Monir El AzzouziI know you are struggling with that so I will explain to you what we learned applying to multiple Notified Bodies. This is difficult and you should really plan the process ahead and not wait the last minute. The post...How to select your Notified Body and understand the full process? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>199513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-become-the-best-prrc-ever-ronald-How to become the best PRRC ever? [Ronald Boumans] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2896Tue, 20 Sep 2022 00:00:00 +0000Monir El AzzouziPRRC is a 4 letters acronym for Person Responsible for Regulatory Compliance and you need a person to act as PRRC but also a person that can really understand how to become the best PRRC. So let's learn more about it on this podcast episode. The post...How to become the best PRRC ever? [Ronald Boumans] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>236113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/why-do-you-need-an-initial-importer-for-Why do you need an Initial Importer for the US Market? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2887Tue, 13 Sep 2022 00:20:00 +0000Monir El AzzouziThis is not anymore a question, you need an Importer for the US market. But what are the rules and who can do this. Stéphen Toupin from Dawa Medical will help us understand why your products are blocked at the US Customs. The post...Why do you need an Initial Importer for the US Market? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>164913485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-september-2022-regulMedical Device News: September 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2873Tue, 06 Sep 2022 02:50:00 +0000Monir El AzzouziMedical Device News is your summary of what happened in the Medical Device Field. I am providing you with the September 2022 Regulatory Update. Enjoy! The post https://podcast.easymedicaldevice.com/196/ appeared first on...Medical Device News: September 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>207813485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/samd-or-simd-how-to-create-your-design-dSaMD or SiMD – How to create your Design Dossier? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2863Tue, 30 Aug 2022 00:00:00 +0000Monir El AzzouziThe Design Dossier of your Medical Device is really important. But what about a Software as a Medical Device. You will learn today some good practices to create them. The post https://podcast.easymedicaldevice.com/195/ appeared first on...SaMD or SiMD – How to create your Design Dossier? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>199213485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/new-blue-guide-what-is-the-impact-on-medNew Blue Guide – What is the impact on Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2852Tue, 23 Aug 2022 01:00:00 +0000Monir El AzzouziThe New Blue Guide is a guidance document that is really important to CE marking. And this has also some impact on the interpretation of the Medical Device legislation like EU MDR and IVDR. So don't miss this episode where we interpret what are the...New Blue Guide – What is the impact on Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>225513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/why-are-we-not-discontinuing-your-producWhy are we not Discontinuing your Products? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2843Tue, 16 Aug 2022 01:00:00 +0000Monir El AzzouziWhy are you not discontinuing your products? I am not talking about just deleting the reference on your portfolio but obsoleting the documents linked to this product. The post https://podcast.easymedicaldevice.com/193/ appeared first on...Why are we not Discontinuing your Products? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>241913485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/when-you-think-510k-but-fda-says-denovo-When you think "510k" but FDA says "DeNovo" with Spencer Jones appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2817Tue, 09 Aug 2022 00:00:00 +0000Monir El AzzouziWhat would you think if you planned all your regulatory strategy for FDA 510k and when you submit, the FDA says to you that this should go DeNovo. Spencer Jones will tell us what he learned during this process. The post...When you think "510k" but FDA says "DeNovo" with Spencer Jones appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>223813485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-create-your-technical-documentatiHow to create your Technical Documentation? [EU MDR and IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2827Tue, 02 Aug 2022 00:00:00 +0000Monir El AzzouziI get a lot of messages about the creation of Technical Documentation and I want to share with you how I am doing it. Don't hesitate to check the link in the show notes for more details. The post https://podcast.easymedicaldevice.com/191/ appeared...How to create your Technical Documentation? [EU MDR and IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>186813485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/maybe-you-need-a-cleanroom-let-s-check-wMaybe you need a Cleanroom? Let's check with Philippe Bourbon appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2808Tue, 26 Jul 2022 00:00:00 +0000Monir El AzzouziThe use of a cleanroom is something that depends on your products. Philippe Bourbon from the laboratory Icare will explain to us what exactly is needed to install and maintain cleanrooms. The post https://podcast.easymedicaldevice.com/190/ appeared...Maybe you need a Cleanroom? Let's check with Philippe Bourbon appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>204213485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/ai-act-vs-eu-mdr-2017-745-are-they-compaAI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2795Tue, 19 Jul 2022 00:00:00 +0000Monir El AzzouziIf you are working with Artifical Intelligence for your Medical Devices, then this episode is for you. We are alerting you about the new legislation that is planned for all Artificial Intelligence software. Not only medical devices, but they are...AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>217113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medtech-europe-forum-interviews-mdr-eudaMedtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2784Tue, 12 Jul 2022 02:50:00 +0000Monir El AzzouziDuring my visit to the Medtech Europe Forum I had the chance to meet Fabien, Peter, Ronald, Inna and Rana. They shared with me some great information. Don't miss their interview. The post https://podcast.easymedicaldevice.com/188/ appeared first on...Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>213513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-july-2022-regulatoryMedical Device News – July 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2771Tue, 05 Jul 2022 02:00:00 +0000Monir El AzzouziThis podcast episode is the monthly review of the regulatory situation. Don't forget to download the document with all the links. The post https://podcast.easymedicaldevice.com/187/ appeared first on https://podcast.easymedicaldevice.com....Medical Device News – July 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>164013485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/attention-1-year-before-ukca-is-the-law-Attention! 1 year before UKCA is the law for Medical Devices in the UK appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2758Tue, 28 Jun 2022 00:00:00 +0000Monir El AzzouziThis is your last year to be compliant to UKCA otherwise Bye Bye the UK market. We tell you everything with Adam Rae on this episode. So listen carefuly and don't forget to download the cheat sheet. The post https://podcast.easymedicaldevice.com/186/...Attention! 1 year before UKCA is the law for Medical Devices in the UK appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>211613485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/why-is-it-great-for-importers-to-be-iso-Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2747Tue, 21 Jun 2022 00:00:00 +0000Monir El AzzouziWe may think that ISO 13485 certification is only for Medical Device manufacturers but in this episode you will hear Cristina Miroescu from Sofmedica Group tell us why its company decided to be certified even if they are not manufacturing devices. The...Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>196613485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/what-are-some-quality-common-mistakes-kaWhat are some Quality Common Mistakes? [Karandeep Badwal] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2736Tue, 14 Jun 2022 02:00:00 +0000Monir El AzzouziKarandeep Badwal will list us some of the common mistakes that he has always noticed. I will confirm some of them. If you are able to solve those you have made already 70% of the problems resolved. Enjoy! The post...What are some Quality Common Mistakes? [Karandeep Badwal] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>172213485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-june-2022-regulatoryMedical Device News: June 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2725Tue, 07 Jun 2022 02:30:00 +0000Monir El AzzouziMedical device news June 2022 is focusing on IVDR 2017/746 date of applciation and consequences. Don't miss all the additional information on guidances, Training,,, The post https://podcast.easymedicaldevice.com/183/ appeared first on...Medical Device News: June 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>145113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/let-s-introduce-you-to-our-eqms-smarteyeLet's introduce you to our eQMS SmartEye with Anindya Mookerjea appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2714Tue, 31 May 2022 00:43:00 +0000Monir El AzzouziWe have worked since more than a year on an eQMS called SmartEye and I have invited Anindya Mookerjea the CEO of SCube Technologies to present the tool and talk about the advantages of electronic Quality Management Systems. The post...Let's introduce you to our eQMS SmartEye with Anindya Mookerjea appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>192813485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/what-to-learn-about-the-eu-medical-devicWhat to learn about the EU Medical Device situation? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2703Tue, 24 May 2022 00:45:00 +0000Monir El AzzouziMedtech Forum was really a great event with all the Medical Device stakeholders at the same place. Manufacturers, Consultants, Notified Body, European Commission, trade associations, service providers. Let's summarize that with Erik Vollebregt. The...What to learn about the EU Medical Device situation? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>161613485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/what-happens-after-the-ivdr-date-of-applWhat happens after the IVDR Date of Application with Colm O'Rourke appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2685Tue, 17 May 2022 00:00:00 +0000Monir El AzzouziThe IVDR 2017/746 will go live and this may be a big problem for a lot of companies. We will talk about that with Colm O'Rourke from Trinzo. The IVDR is changing the game so learn about it. The post https://podcast.easymedicaldevice.com/180/ appeared...What happens after the IVDR Date of Application with Colm O'Rourke appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>198213485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-certify-your-software-as-a-medicaHow to certify your Software as a Medical Device? (SaMD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2675Tue, 10 May 2022 00:00:00 +0000Monir El AzzouziSoftware as a Medical Device is an area that is exploding. So understanding how this is working and what to be done is important. Listen to this episode to have more clarity on your projects for EU and US. The post...How to certify your Software as a Medical Device? (SaMD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>202413485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-may-2022-regulatory-Medical Device News: May 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2661Tue, 03 May 2022 00:50:00 +0000Monir El AzzouziIn this episode, we will review all the changes related to Quality & Regulatory Affairs for Medical Devices in the month of May 2022. The post https://podcast.easymedicaldevice.com/178/ appeared first on https://podcast.easymedicaldevice.com....Medical Device News: May 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>155813485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/training-process-what-are-the-mistakes-tTraining Process – What are the mistakes to avoid? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2649Tue, 26 Apr 2022 00:30:00 +0000Monir El AzzouziGreat episode with Rod and Katie on Training Requirements. A lot of afvices that can help you pass audits and remain compliant The post https://podcast.easymedicaldevice.com/177/ appeared first on https://podcast.easymedicaldevice.com....Training Process – What are the mistakes to avoid? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>276513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-your-pmcf-is-evaluated-by-your-notifHow your PMCF is evaluated by your Notified Body? [Matthias Fink] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2632Tue, 19 Apr 2022 02:00:00 +0000Monir El AzzouziThis podcast episode will be instrumental for you as PMCF should be part of your strategy. And Matthias Fink from TÜV SÜD will provide you with great advice on how to overcome this task. The post https://podcast.easymedicaldevice.com/176/ appeared...How your PMCF is evaluated by your Notified Body? [Matthias Fink] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>250413485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-prepare-an-audit-with-a-front-rooHow to prepare an Audit with a Front Room & a Back Room? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2624Tue, 12 Apr 2022 01:00:00 +0000Monir El AzzouziHave you ever performed an audit with a Front Room and Back Room? In this episode I will explain to you how this works and what is the interest. This method can help you to have a smooth audit and make your auditor happy. The post...How to prepare an Audit with a Front Room & a Back Room? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>177113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-april-2022-updateMedical Device News: April 2022 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2613Tue, 05 Apr 2022 02:00:00 +0000Monir El AzzouziThe latest news for the Medical Device Community is on the Medical Device News Podcast. We'll talk about EU, US, MEA, Asia, Notified Bodies, Events, Podcasts. So enjoy! The post https://podcast.easymedicaldevice.com/174/ appeared first on...Medical Device News: April 2022 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>152913485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/what-are-the-surprises-during-mdr-ivdr-tWhat are the surprises during MDR & IVDR transition? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2602Tue, 29 Mar 2022 00:00:00 +0000Monir El AzzouziWe update you on the situation regarding the MDR and IVDR transition period. Erik Vollebregt will try to provide an explanation why the EMA will now take the control of the Expert Panel for Medical Devices and also why the proposal for a 2 years or...What are the surprises during MDR & IVDR transition? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>266313485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-sell-medical-devices-online-in-thHow to sell Medical Devices online in the EU and US? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2594Tue, 22 Mar 2022 00:00:00 +0000Monir El AzzouziIf you are selling medical devices online or if you plan to sell some, then this episode is for you. This will help you to understand the struggle that you may have or will encounter. Michael Wetherington and I will provide you the keys to be...How to sell Medical Devices online in the EU and US? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>178313485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/what-lesson-did-we-learn-doing-clinical-What lesson did we learn doing Clinical Evaluations? [Cesare Magri] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2584Tue, 15 Mar 2022 00:43:00 +0000Monir El AzzouziIf you are not sure of your Clinical Evaluation, then maybe by listening that you will have a better understanding of what is expected from you. So don't miss the lesson learned with Cesare Magri The post https://podcast.easymedicaldevice.com/171/...What lesson did we learn doing Clinical Evaluations? [Cesare Magri] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>242013485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/why-do-we-need-the-common-specification-Why do we need the Common Specification for Class D IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2573Tue, 08 Mar 2022 00:00:00 +0000Monir El AzzouziYou will hear more and more about IVDR and now we talk of the Draft Common Specification. Have a look at the explanation from Andreas that will help you be more efficient if your products are on scope. The post...Why do we need the Common Specification for Class D IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>166713485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-march-2022-regulatorMedical Device News – March 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2561Tue, 01 Mar 2022 01:00:00 +0000Monir El AzzouziThis month the big news is about FDA amending QSR to integrate ISO 13485. Not sure on how this will be at the end but it's always cool to have harmonization. No worries, other topics like IVDR, MDCG, UK, Saudi Arabia, Spain are mentioned. Enjoy!!! The...Medical Device News – March 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>142413485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/why-would-you-need-a-swiss-authorised-reWhy would you need a Swiss Authorised Representative and Importer? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2554Tue, 22 Feb 2022 01:00:00 +0000Monir El AzzouziWhat is the role of a Swiss Authorized Representative and Swiss Importer? And most importantly why would you need one? I'll tell you everything on this podcast episode. The post https://podcast.easymedicaldevice.com/168/ appeared first on...Why would you need a Swiss Authorised Representative and Importer? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>155313485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-be-great-at-management-reviews-isHow to be great at Management Reviews? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2548Tue, 15 Feb 2022 00:30:00 +0000Monir El AzzouziManagement Review is one of the most important activity to perform before to be ISO 13485 certified. So today I will explain to you how to be great at it. The post https://podcast.easymedicaldevice.com/167/ appeared first on...How to be great at Management Reviews? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>167713485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/why-design-history-file-dhf-is-so-importWhy Design History File (DHF) is so important? [Alexandros Savvidis] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2538Tue, 08 Feb 2022 00:00:00 +0000Monir El AzzouziDHF is an accronym that people don't really understand and in this episode Alexandros Savvidis he tries to help us have a view of his experience. The post https://podcast.easymedicaldevice.com/166/ appeared first on...Why Design History File (DHF) is so important? [Alexandros Savvidis] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>221513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-february-2022-regulaMedical Device News: February 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2525Tue, 01 Feb 2022 00:00:00 +0000Monir El AzzouziAll the February 2022 updates on MDR and IVDR, Clinical requirements and some news on the guidances and Notified Bodies. The post https://podcast.easymedicaldevice.com/165/ appeared first on https://podcast.easymedicaldevice.com....Medical Device News: February 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>181913485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/mdcg-2021-27-placing-on-the-market-re-laMDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2514Tue, 25 Jan 2022 00:00:00 +0000Monir El AzzouziThe use of certain wording can be a big problem and this is what we will describe here with this MDCG guidance that is not really clarifying the situation but creating more problems. Let us tell you. The post https://podcast.easymedicaldevice.com/164/...MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>264413485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-interview-your-qa-ra-candidates-mHow to interview your QA RA Candidates? [Mitch Robbins] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2505Tue, 18 Jan 2022 00:00:00 +0000Monir El AzzouziWhat is your method to perform an interview? You are not trained as a recruiter so how should you do to interview a QA RA Candidate. This is what Mitch Robbins will explain to you on this episode. So no more misses. The post...How to interview your QA RA Candidates? [Mitch Robbins] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>279713485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-accelerate-your-laboratory-test-rHow to accelerate your Laboratory Test Results? [Christoph Lindner] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2488Tue, 11 Jan 2022 02:00:00 +0000Monir El AzzouziLab Tests can be really tricky for the success of your Medical Device Design. We will help you in this episode to understand with Christoph Lindner. Check show notes for more details. The post https://podcast.easymedicaldevice.com/162/ appeared first...How to accelerate your Laboratory Test Results? [Christoph Lindner] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>257513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-january-2022-happy-nMedical Device News – January 2022 [Happy New Year] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2479Tue, 04 Jan 2022 03:00:00 +0000Monir El AzzouziHAPPY NEW YEAR 2022! Another year passed and this went really fast. But the Medical Device News is still here. So today we will talk of all the releases done in December 2021 and what is planned for the following months. Don't miss it. This will save...Medical Device News – January 2022 [Happy New Year] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>182613485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/what-happened-in-2021-summary-for-the-meWhat happened in 2021? Summary for the Medical Device Industry appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2471Tue, 28 Dec 2021 02:00:00 +0000Monir El AzzouziI know, already the end of 2021. So many things happened that this may be difficult to summarize. So I've tried to put my TOP information on this episode. I also share with you the new projects for Easy Medical Device so don't hesitate to contact us...What happened in 2021? Summary for the Medical Device Industry appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>113613485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/the-step-by-step-recipe-to-get-mdr-ivdr-The Step-by-Step recipe to get MDR & IVDR Certified appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2464Tue, 21 Dec 2021 02:00:00 +0000Monir El AzzouziFor this christmas season, I wanted to summaries the situation on how to get MDR & IVDR certified. So i made this step-by-step recipe where you just need to follow. I hope you'll enjoy. The post https://podcast.easymedicaldevice.com/159/ appeared...The Step-by-Step recipe to get MDR & IVDR Certified appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>179613485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/which-devices-cannot-be-custom-made-erikWhich devices cannot be Custom-made? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2454Tue, 14 Dec 2021 00:00:00 +0000Monir El AzzouziIf you are not aware, the EU MDR 2017/745 is completely changing the definition of Custom-made devices and this is mainly what we will try to explain to you on this episode. If you still have some question,s don't hesitate to contact me. The post...Which devices cannot be Custom-made? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>264613485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-december-2021-regulaMedical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2272Tue, 07 Dec 2021 02:00:00 +0000Monir El AzzouziHere is the last Medical Device News for this year, I will cover all the updates that happen in the EU, UK, Switzerland,, US and Saudi Arabia. We will also review the situation for Notified Bodies. I hope you'll enjoy. The post...Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>183613485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/let-s-unleash-mdr-classification-surprisLet's unleash "MDR Classification surprises" [MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2259Tue, 30 Nov 2021 02:00:00 +0000Monir El AzzouziThe MDR classification was hidding some surprises and I have asked Frank Matzek from Biotronik to tell us more about the products and rules we need to take care of. So Enjoy! The post https://podcast.easymedicaldevice.com/156/ appeared first on...Let's unleash "MDR Classification surprises" [MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>275113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-approach-your-notified-bodies-dr-How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2251Tue, 23 Nov 2021 02:00:00 +0000Monir El AzzouziReally great discussion with Dr Royth von Hahn from TÜV SÜD. He is providing some solutions on how to talk to your Notified Body. This would help Medical Device manufacturers. The post https://podcast.easymedicaldevice.com/155/ appeared first on...How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>265213485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/is-it-possible-to-private-label-a-medicaIs it possible to Private Label a Medical Device under MDR & IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2232Tue, 16 Nov 2021 02:18:00 +0000Monir El AzzouziOEM OBL is really used a lot by Medical Device Manufacturers. But this is not possible anymore with EU MDR. So please listen to that as maybe you are doing it without knowing. The post https://podcast.easymedicaldevice.com/154/ appeared first on...Is it possible to Private Label a Medical Device under MDR & IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>208213485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-improve-your-qa-ra-communication-How to improve your QA RA Communication with Lesley Worthington? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2219Tue, 09 Nov 2021 02:00:00 +0000Monir El AzzouziLesley Worthington is a career coach and will help you understand why improving your communication skills within QA RA can be a booster for you. We will talk about our experience as she also worked in QA RA. So don't miss this episode if you don't...How to improve your QA RA Communication with Lesley Worthington? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>201613485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-november-2021-latestMedical Device News – November 2021 latest update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2208Tue, 02 Nov 2021 03:00:00 +0000Monir El AzzouziLatest update will focus on IVDR proposal, Artificial intelligence, Notified Bodies situation and MDCG guidances. Other elements will also be discussed. I hope you'll enjoy! The post https://podcast.easymedicaldevice.com/152/ appeared first on...Medical Device News – November 2021 latest update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>214113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-does-the-eu-commission-plan-to-save-How does the EU Commission plan to save IVDR 2017/746? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2183Tue, 26 Oct 2021 01:20:00 +0000Monir El AzzouziBREAKING NEWS: The EU Commission issued a proposal to delay some IVDR date of application but it is not a complete postponment so don't use this word. Listen the interpretation of Erik Vollebregt on that. The post...How does the EU Commission plan to save IVDR 2017/746? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>218913485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-comply-with-mdr-when-products-conHow to comply with MDR when products contain CMR Substances? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2170Tue, 19 Oct 2021 02:00:00 +0000Monir El AzzouziAna Luiza is my guest and we will explain to you how to be sure that your are compliant with CMR substances on your product. CMR will be reviewed during an audit and apparently there were a lot of mistakes. So let's help you to avoid that. The post...How to comply with MDR when products contain CMR Substances? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>139513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/eudamed-update-should-you-register-your-EUDAMED Update: Should you register your medical devices now? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2159Tue, 12 Oct 2021 02:00:00 +0000Monir El AzzouziEUDAMED is the database that will provide all the information about your company and your devices. After the release of the Economic Operator module, now there is the release of the Device Registration and Certificate Module. So let's talk about that...EUDAMED Update: Should you register your medical devices now? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>272713485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-october-2021-regulatMedical Device News – October 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2146Tue, 05 Oct 2021 02:30:00 +0000Monir El AzzouziHere is the Regulatory update for October 2021. We will talk of the Implementation of MDR and IVDR, MHRA, Swissmedic, FDA, AEMPS.. A new session of the Green Belt opens this month. The post https://podcast.easymedicaldevice.com/148/ appeared first on...Medical Device News – October 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>213913485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/why-does-an-importer-distributor-need-toWhy does an Importer/Distributor need to appoint a Notified Body? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2136Tue, 28 Sep 2021 00:00:00 +0000Monir El AzzouziThe MDR and IVDR has not finished to surprise us. On this episode we will talk about the article 16(4) where we see that in certain circumstances, an importer or Distributor will need to get certified by a Notified Body even if they are not doing a...Why does an Importer/Distributor need to appoint a Notified Body? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>269913485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-collect-clinical-data-within-the-How to collect Clinical Data within the 21st Century [Jon Bergsteinsson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2128Tue, 21 Sep 2021 01:00:00 +0000Monir El AzzouziAre you starting a clinical investigation or PMCF? Then are you using a Digital Solution to collect the data? Today we will explain to you what is The post https://podcast.easymedicaldevice.com/146/ appeared first on...How to collect Clinical Data within the 21st Century [Jon Bergsteinsson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>206113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-manage-the-ivdr-transition-periodHow to manage the IVDR transition period? [IVDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2119Tue, 14 Sep 2021 00:00:00 +0000Monir El AzzouziWe have passed the Date of application for MDR and this went well because a lot of manufacturers do have CE certificates that expire later. But for IVDR this is another story. So for the majority of the products, they should be compliant by the date...How to manage the IVDR transition period? [IVDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>165513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/is-it-a-good-idea-to-sue-my-notified-bodIs it a good idea to sue my Notified Body? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2091Tue, 07 Sep 2021 00:00:00 +0000Monir El AzzouziMaybe some of dreamed of it, maybe this idea went through your mind but you haven't done it. Here we will talk with Erik Vollebregt of the consequences of opening a legal case with your Notified Body. The post...Is it a good idea to sue my Notified Body? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>205713485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-september-2021-latesMedical Device News – September 2021 Latest Updates appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>https://podcast.easymedicaldevice.com/?p=2083Tue, 31 Aug 2021 00:00:00 +0000Monir El AzzouziOn this September 2021 update we will talk about FDA, MHRA, Swissmedic, ANSM, Fimea, MDCG guidances, New Notified Bodies... A lot to talk about so don't miss this update. If you are not willing to read the guidances, let me summarize it for you. The...Medical Device News – September 2021 Latest Updates appeared first on Medical Device made Easy Podcast. Monir El Azzouzi]]>181813485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-august-2021-regulatohttps://podcast.easymedicaldevice.com/?p=2039Tue, 03 Aug 2021 00:00:00 +0000Monir El AzzouziThis is already Mi-Year with the summer holiday. But EU Commission didn't sleep as there was a lot of MDCG guidance released. Let's review the agenda for this month and don't miss all the links. The post Medical Device News – August 2021 Regulatory...158813485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-find-a-qa-ra-job-for-medical-devihttps://podcast.easymedicaldevice.com/?p=1739Tue, 16 Feb 2021 00:00:00 +0000Monir El AzzouziHow to find a job in the QA RA world for Medical Devices? This is what we will discuss with Karandeep Badwal. We will provide our tips and also the platforms to visit. The post How to find a QA RA job for Medical Devices? [Karandeep Badwal] appeared...166413485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/what-is-the-qa-ra-mindset-with-michelle-https://podcast.easymedicaldevice.com/?p=1731Tue, 09 Feb 2021 00:00:00 +0000Monir El AzzouziIf you are thinking that you are the only one that has issues as QA RA, then listen to this episode. I hope this will help you to understand that there is a certain mindset to have when you do this type of job. The post What is the QA RA Mindset with...220113485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/february-2021-update-medical-devices-remhttps://podcast.easymedicaldevice.com/?p=1720Tue, 02 Feb 2021 00:00:00 +0000Monir El AzzouziOn this podcast episode, we'll perform the February 2021 update. What happened in the Medical Device World. One of the HOT TOPICS is the Remote audit authorization by the EU Commission but we'll see this is not so easy. The post February 2021 Update –...129413485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-get-the-mdr-certification-for-arthttps://podcast.easymedicaldevice.com/?p=1696Tue, 19 Jan 2021 00:00:00 +0000Monir El AzzouziThe new EU MDR is now taking into account dangerous Software as a Medical Device SAMD. In this episode we will talk specifically about Artificial Intelligence Software. How to make them safe and efficient to be EU MDR certified? Listen to know. The...216713485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-to-register-a-medical-device-in-israhttps://podcast.easymedicaldevice.com/?p=1678Tue, 12 Jan 2021 00:00:00 +0000Monir El AzzouziLiat Nadel is the CEO of L.S. Marketing & Registration. She will help us to understand the context for the registration of Medical Devices in Israel. The post How to register a Medical Device in Israel? (Liat Nadel) appeared first on Medical Device...188213485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/how-easy-medical-device-can-help-you-monhttps://podcast.easymedicaldevice.com/?p=1658Mon, 28 Dec 2020 00:00:00 +0000Monir El AzzouziThis is the last episode of 2020 and I wanted to share with you the progress of the Easy Medical Device project. I will also tell you the next steps that I will try to achieve. Let me know how I can help you? The post How Easy Medical Device can help...134313485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/medical-device-news-what-happened-in-novhttps://podcast.easymedicaldevice.com/?p=1620Mon, 07 Dec 2020 00:00:00 +0000Monir El AzzouziThis November update is providing a lot of information on what you should not miss. We will talk Brexit, Eudamed, Jobs, Training... A lot of topic to help you stay up-to-date. The post Medical Device News: What happened in November 2020? appeared...197713485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/is-it-easy-for-a-notified-body-to-get-euhttps://podcast.easymedicaldevice.com/?p=1593Mon, 30 Nov 2020 00:00:00 +0000Monir El AzzouziIn this episode, we will hear the journey of a Notified Body to get EU MDR accredited. We hope this will help you to understand how difficult it is and why you should be patient with your Notified Body. The post Is it Easy for a Notified Body to get...174613485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/do-you-need-an-expert-panel-for-your-medhttps://podcast.easymedicaldevice.com/?p=1568Mon, 16 Nov 2020 00:00:00 +0000Monir El AzzouziIf you thought that clinical evaluation was already difficult to work on with the new EU MDR, then listen to this episode where we will tell you about the new level of difficulty that is coming soon. The post Do you need an Expert Panel for your...182413485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfullhttps://www.spreaker.com/user/easymedicaldevice/we-ve-reached-episode-100-what-happened-https://podcast.easymedicaldevice.com/?p=1539Mon, 02 Nov 2020 00:00:00 +0000Monir El AzzouziWe have reached 100 episodes on the podcast and today we will celebrate that. Here is an episode with some of the great influencers in the Medical Device field which are sharing with us their journey. What happened to you since the last years. The...173513485,2017/745,affairs,anvisa,audits,compliance,device,eu,fda,industry,iso,management,mdr,medical,medtech,quality,regulation,regulatory,system,tgacleanfull