MEDTECH 2016

BREAKOUT SESSION 1

REGULATORY & POLICY TRACK: Regulatory Deep Dive

Governor D

This extended panel will begin with a broad discussion on recent regulatory changes and how new developments impact the medical device, pharmaceutical and health information technology segments. Topics include changes to submission processes, clinical labs and lab practices, consumable products, electrical safety testing and unique device identifier (UDI) packaging regulations.


Discussion Points:

- What is the forecast for the regulatory environment over the next year?
- How will the upcoming Presidential election affect the regulatory environment?
- At what stage of your product development should you begin safety testing?
- How does the change in UDI packaging regulations affect your manufacturing process? How do you prepare for future changes?

Speakers: