International conference details
FDA Changes
Device Changes, FDA Changes, and the 510(k) 2017
Fremont (United States), 25 January 2017
Domain:
Key deadlines
- Conference starts:
- 2017-01-25
Website
Conference Description
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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
For full datails & Event Link : http://www.compliance4all.com/control/w_product/~product_id=501053LIVE?channel=mailer&camp=Webinar&AdGroup=confroll_Jan_2017_SEO
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Conference Location
161 Mission Falls Lane, Suite 216,,
Fremont 94539 (United States)