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: