Medical Device Change(s), Analysis and 510(k) Impact

Instructor: John E Lincoln
Product ID: 701742
Training Level: Intermediate
  • Duration: 90 Min

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Read Frequently Asked Questions

This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011.

Why Should You Attend:

Control of medical device changes and a current 510(k) are big issues in recent FDA studies. Companies are held fully responsible for deciding when a new 510(k) filing is warranted. Often this is a difficult decision process. Effective change control and the power of current risk management tools must be a major part of such an analysis.

The U.S. FDA has its current K-97-1 Memorandum and has published a New Draft Guidance Document, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", on July 27, 2011, which provides companies tools to perform meaningful, results driven 510(k) / change analysis activities. This is part of a growing push by the Agency to strengthen the 510(k) process. The addition of simple tools will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when a new 510(k) needs submission.

This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo as well as their new draft guidance document, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", will provide tools to document such decisions. It will also prepare the industry for further 510(k) changes in the future.

Areas Covered in the Seminar:

  • Current Requirements of the K 97-1 Memorandum, and FDA Expectations
  • Expected sources of information for evaluation and inclusion
  • Two approaches to the use of FDA's K97-1 Memo
  • Change reporting "tipping point" -- with one change or cumulative
  • Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes
  • Which of the three major 510(k) formats should be used
  • How to complete, document and control as a 'living' document

Who Will Benefit:

This webinar will benefit companies in the medical device and combination products fields. The employees who will benefit include:

  • Senior management
  • Regulatory affairs
  • Quality Assurance
  • Production
  • R&D and Engineering
  • All personnel tasked with new and changed product development and documentation

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years experience in U.S. FDA-regulated industries, 17 years as a full-time consultant. 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. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on all CGMP subjects. John is a graduate of UCLA.

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