Conference Details

Device Changes, FDA Changes, and the 510(k)

Date :

Place : United States, Fremont

Website :

Contact LLC


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".

Device Changes, FDA Changes, and the 510(k) will be held in Fremont,United States on date 2019-05-21

Deadline for abstracts/proposals : 21st May 2019

Organized By LLC

Keynote Speakers : John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, r

Conference Highlights :U.S. FDA device clearance / approval FDA's and EU's emphasis Product changes and filing a new 510(k) - who's responsible Tracking and evaluating changes - the "tipping point" Is the process "risk based"? K-97-1 and the FDA's "Decision Tree" Documenting the process / rationale Resolving a "wrong decision"

Venue :Fremont, CA, USA

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Device Changes, FDA Changes, and the 510(k)

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