- TypeWebinar
- Location San Diego, California, United States
- Date 25-01-2017
Education/Teaching/Training/Development
Business Development
Medical/Healthcare/Hospital
Administration/Management
OVERVIEW:
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
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This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?
Product Id : 501053
Instructor : John E Lincoln
Areas Covered in the Session:
Who Will Benefit:
IMPORTANT DATE:
Webinar Date:Â Wednesday, January 25, 2017 | 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
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