Finally got my copy of this interesting book on grey literature, which has great impact on medical device regulatory compliance. One of the definitions of…
Posts published in “Guidance MEDDEV”
How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities
How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities
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…
Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8