Question: I just heard about an FDA initiative for medical devices, called Case for Quality. What is it and how is it different from the current Design Controls? Answer: Design controls were enacted in 1997 by the FDA as a way to improve medical device quality. However, they observed that products can be fully compliant […]
Question: Introducing medical devices to the market seems more complicated than product launches I’ve done in other industries. Why is that? Answer: Medical device product launches have some …
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