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Device Changes, FDA Changes, and the 510(k) Usa 2017 webinar by Compliance4all

 
  November 17, 2016  
     
 
Compliance4All, Online
2017-01-25


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




 
 
Organized by: Compliance4All
Invited Speakers:
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. 
 
Deadline for Abstracts: 2017-01-24
 
Registration:
Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
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E-mail: support@compliance4All.com
 
   
 
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