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Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

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