So after reviewing some concepts for a Clinical Evaluation training I gave this week, some people asked me about sources of literature on how to…
How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities
April 20, 2024
News, opinions and insights about medical device regulations and standards
So after reviewing some concepts for a Clinical Evaluation training I gave this week, some people asked me about sources of literature on how to…
Special Premarket Notification [510(k)] Pathway
Novartis Inhaler is First Device to be Certified Under MDR
Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and…
Cybersecurity in Medical Devices: Communication That Empowers Patients.
Webinar: The cybersecurity of medical devices