Device Changes and the 510(k) - By AtoZ Compliance.

Speaker: John E. Lincoln

Key Take Away

Understand the approaches required for Medical Device product changes; if it’s a risk-based process and how to maximize the process against scarce resources giving different considerations for CE-marked products.

Overview

The FDA holds companies responsible for filing new 510(k) training when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes?

Why Should You Attend

The majority of medical devices are cleared for marketing in the U.S. by the FDA 510(k) process.

Areas Covered In This Webinar

What approaches are required for product changes; for process changes? How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?

Learning Objectives

• U.S. FDA device clearance / approval
• FDA's and EU's emphasis
• Product changes and filing a new 510(k) clearance – who's responsible
• Tracking and evaluating changes – the "tipping point"
• Is the process "risk based"?
• K-97-1 and the FDA's medical device approval
• Documenting the process / rationale
• Resolving wrong 510(k) submissions

Who Will Benefit

• Senior Management, Project Leaders, Internal / External Consultants
• Regulatory Affairs Personnel 
• Quality Systems Personnel 
• R&D and Engineering Staff
• Personnel involved in Lean and Six Sigma Initiatives
• CAPA Personnel

Level

Beginner

For more information, please visit http://bit.ly/1o0Ozsl 

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