Category: Guidance MEDDEV

Grey literature and medical devices

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 grey literature is: “Grey literature stands for manifold document types produced on all levels of government, academics, business and industry in print and electronic formats that are protected by intellectual […]

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 perform a clinical evaluation. I notice that a lot of people does not seem to not that a clinical evaluation is nothing more than a specific application of a systematic […]