Diapason Consulting

Notified Bodies

Medical Devices Regulations 101

Regulations are a complex topic. According to Feynman, the best way to master a complex topic is to: (1) study it (2) explain it simply (3) fill any gap. Here’s my 2cts at step 2, which I wrote for a collaborative project. Feedback welcome for step 3. National or multinational (EU) regulations impose various requirements for the commercialization of medical devices within (or from) their jurisdictions, that consist in - roughly:

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