EN ISO 14971 - Risk Management

Presenter: David Amor, Managing Partner at Medgineering

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David Amor, MSBE, CQA is a medical device consultant and mobile health entrepreneur. In 2009, David founded Medgineering, a company focused on remote compliance & quality systems consulting for larger companies and start-ups alike.

He is also a co-inventor of QuickConsult, a medtech consulting marketplace where you find, hire and manage vetted consultants in regulatory, quality, reimbursement and other areas of expertise.

A graduate of the Senior Innovation Fellows program at the University of Minnesota’s Medical Device Center, David was named a Top 40 Under 40 Medical Device Innovator in 2012. David is a risk management subject matter expert having implemented new ISO 14971:2012 compliance programs at companies such as Boston Scientific and St. Jude Medical, as well as a number of start-ups. Furthermore, David developed a mini-course for several medical device companies called “Integration of risk management into the product development process” which focuses on lean implementation of risk management at the various PDP stages.