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TODAY :
EVENT DATE
Jan 2017
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Webinar on Device Changes, FDA Changes, and the 510(k)

Online Event
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Overview

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/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501053LIVE?channel=mailer&camp=Webinar&AdGroup=eventsinamerica_Jan_2017_SEO
Twitter Follow us – https://twitter.com/compliance4all    
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