MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
Posts tagged as “Clinical Evaluation”
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
So here’s is a tip related to the use of the NOT Boolean operator as part of your search strategy (tI wrote this from a…
IMDRF Final Documents – Clinical Evidence, Clinical Evaluation and Clinical Investigation
Observation 1 – This is the third installment of my series on medical device clinical evaluation. I suggest reading the first part at (http://www.medicaldevice.expert/) to…
Related to my post yesterday about medical device clinical evaluation and EBP (Evidence-Based Practice), this recent book (published late last year) is already a classic…
This is the second installment of my series on medical device clinical evaluation. I suggest reading the first part (How to perform a clinical evaluation…
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…
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…
Análise do impacto da avaliação clínica no registro sanitário de dispositivos médicos de alto risco. Conclusões:Considerando a amostra de indeferimentos de registro sanitário estudada, os…