#13485

How to accelerate your Laboratory Test Results? [Christoph Lindner]
How to accelerate your Laboratory Test Results? [Christoph Lindner]
What do Clients, Followers, Team, … think of Easy Medical Device?
What do Clients, Followers, Team, … think of Easy Medical Device?
Your Software/IVD clinical report is completely WRONG!
Your Software/IVD clinical report is completely WRONG!
What are the surprises during MDR & IVDR transition? [Erik Vollebregt]
What are the surprises during MDR & IVDR transition? [Erik Vollebregt]
Why Design History File (DHF) is so important? [Alexandros Savvidis]
Why Design History File (DHF) is so important? [Alexandros Savvidis]
Can you go to Jail as a PRRC? [Elem Ayne]
Can you go to Jail as a PRRC? [Elem Ayne]
New Blue Guide – What is the impact on Medical Devices?
New Blue Guide – What is the impact on Medical Devices?
Why Risk Management is important to Medical Device development?
Why Risk Management is important to Medical Device development?
Biological Evaluation: Top Big mistakes
Biological Evaluation: Top Big mistakes
Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]
Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]
Is EU MDR extended? with Erik Vollebregt
Is EU MDR extended? with Erik Vollebregt
Which devices cannot be Custom-made? [Erik Vollebregt]
Which devices cannot be Custom-made? [Erik Vollebregt]
Let’s unleash “MDR Classification surprises” [MDR 2017/745]
Let’s unleash “MDR Classification surprises” [MDR 2017/745]
Medical Device News – January 2022 [Happy New Year]
Medical Device News – January 2022 [Happy New Year]
Medical Device News: December 2021 Regulatory Update
Medical Device News: December 2021 Regulatory Update
How to evaluate Benefit-Risk Ratio for Medical Devices?
How to evaluate Benefit-Risk Ratio for Medical Devices?
The Step-by-Step recipe to get MDR & IVDR Certified
The Step-by-Step recipe to get MDR & IVDR Certified
Is it possible to Private Label a Medical Device under MDR & IVDR?
Is it possible to Private Label a Medical Device under MDR & IVDR?
Attention! 1 year before UKCA is the law for Medical Devices in the UK
Attention! 1 year before UKCA is the law for Medical Devices in the UK
What happened in 2021? Summary for the Medical Device Industry
What happened in 2021? Summary for the Medical Device Industry
How to create your Technical Documentation? [EU MDR and IVDR]
How to create your Technical Documentation? [EU MDR and IVDR]
Medical Device News: September 2022 Regulatory Update
Medical Device News: September 2022 Regulatory Update
How does the EU Commission plan to save IVDR 2017/746?
How does the EU Commission plan to save IVDR 2017/746?
What are some Quality Common Mistakes? [Karandeep Badwal]
What are some Quality Common Mistakes? [Karandeep Badwal]
Medical Device News – July 2022 Regulatory Update
Medical Device News – July 2022 Regulatory Update
How to certify your Software as a Medical Device? (SaMD)
How to certify your Software as a Medical Device? (SaMD)
When you think “510k” but FDA says “DeNovo” with Spencer Jones
When you think “510k” but FDA says “DeNovo” with Spencer Jones
Grow your LinkedIn Profile with Karandeep Badwal
Grow your LinkedIn Profile with Karandeep Badwal
How to be MDSAP certified for your Medical Devices?
How to be MDSAP certified for your Medical Devices?
How to become the best PRRC ever? [Ronald Boumans]
How to become the best PRRC ever? [Ronald Boumans]
Regulatory Pathway: How to reach the US market? [510k exempt]
Regulatory Pathway: How to reach the US market? [510k exempt]
How to improve the relationship between QA – RA and Marketing?
How to improve the relationship between QA – RA and Marketing?
Medical Device News: February 2023 Regulatory Update
Medical Device News: February 2023 Regulatory Update
Maybe you need a Cleanroom? Let’s check with Philippe Bourbon
Maybe you need a Cleanroom? Let’s check with Philippe Bourbon
Is it a good idea to sue my Notified Body? [Erik Vollebregt]
Is it a good idea to sue my Notified Body? [Erik Vollebregt]
MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC
MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC
How to select your Notified Body and understand the full process?
How to select your Notified Body and understand the full process?
Why do you need an Initial Importer for the US Market?
Why do you need an Initial Importer for the US Market?
Medical Device News – December 2022 Regulatory Update
Medical Device News – December 2022 Regulatory Update
How to choose the best Sterilization Method for Medical Devices?
How to choose the best Sterilization Method for Medical Devices?
What lesson did we learn doing Clinical Evaluations? [Cesare Magri]
What lesson did we learn doing Clinical Evaluations? [Cesare Magri]
Why do we need the Common Specification for Class D IVDR?
Why do we need the Common Specification for Class D IVDR?
How to sell Medical Devices online in the EU and US?
How to sell Medical Devices online in the EU and US?
Medical Device News: June 2022 Regulatory Update
Medical Device News: June 2022 Regulatory Update
Medical Device News – November 2021 latest update
Medical Device News – November 2021 latest update
Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED)
Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED)
Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea
Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea
MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt
MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt
Medical Device News – November 2022 Regulatory Update
Medical Device News – November 2022 Regulatory Update
Breaking News: EU MDR Extension Proposal is out for consultation
Breaking News: EU MDR Extension Proposal is out for consultation
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