Medical Device v2.0: Safer but Riskier?
Medical device development is driven by the concept of continuous improvement. Matt Marshall of Clark Hill will discuss the requirements of GMP relating to product improvement, the potential risks of such improvements in litigation, and how such improvements may run afoul of a device’s existing FDA clearance.
00:00 – Introduction of the Presenter
02:16 – What is meant by “continuous improvement” in the medical device context and why is it important?
07:08 – How does device improvement potentially impact litigation?
18:53 – How does device improvement implicate regulatory concerns?
39:57 – What are some best practices when it comes to device improvements?
45:00 – Questions
