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Digital Health Solutions & Risk Management in the Regulated Space

Suraj Ramachandran (Director, Regulatory Affairs, Merck)

Location: 210D

Date: Tuesday, February 5

Time: 11:00am - 11:45am

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

There is no question that medical devices have significantly improved the quality of countless lives. At the same time, however, those benefits often cannot be achieved without risk. Advancements in technology that have brought forward many digital health solutions and have sparked an evolution of regulations to align and catch up to the evolving landscape.

Topics covered include:
  • Steps for managing digital product risk
  • Update on the FDA’s Digital Health Innovation Plan
  • Downstream effects for startups as well as established medical device manufacturers

Presentation File

Digital_Health_Solutions__Risk_Management_in_the_Regulated_Space.pptx