Device Changes, FDA Changes, and the 510(k) webinar by Compliance4all
- Start Date:
- Wednesday, 25 January, 2017
- End Date:
- Wednesday, 25 January, 2017 11:00am
- Health & Nutrition
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". Areas Covered in the Session: 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" Who Will Benefit: Senior management, project leaders, internal / external consultants Regulatory affairs Quality systems personnel / QAE R&D and engineering staff Speaker Profile: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.
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- 161 Mission Falls Lane, Suite 216