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The 21 Elements of a 510(k) - Webinar By ComplianceOnline

  May 08, 2012  
ComplianceOnline, Online Webinar

Why Should You Attend:-

The U.S. FDA mandates that the traditional 510(k) submission address 21 basic requirements. The "Special" and "Abbreviated" 510(k)s must also address them, but in different ways. In addition, the FDA Task Force has identified several problem areas with the existing medical device 510(k) process, leading to the growing push by the Agency to strengthen the 510(k) process. What can companies do proactively to address these concerns and better ensure a smoother review process?

Areas Covered in the Seminar:-

  • The Three Types of 510(k)s and Their Uses.
  • The 21 Required Elements in the 510(k), and How Documented.
  • Finding, Proving and Documenting Substantial Equivalence.
  • Addressing Product "With-" or "As-software" Issues.
  • The "Statement" or The "Summary".
  • Documenting "Hazards Analysis", and the MAUDE Database.
  • The Declarations.
  • U.S. FDA Device Clearance Process.

Who Will Benefit:-

  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • R&D and Engineering


Organized by: ComplianceOnline
Invited Speakers: John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. 
Deadline for Abstracts: 2012-06-05
For registration :- 
E-mail: referral@complianceonline.com
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