ComplianceOnline Webinar - Medical Device Changes and The 510(k)(September 21, Tuesday 10:00 AM PDT | 01:00 PM EDT)

This 510(k) webinar training will discuss how to do a meaningful result drive 510(k)/change analysis activity so as to satisfy FDA requirements.
Areas Covered in the Seminar:

  • Key requirements of the three types of 510(k)s.
  • Product changes and filing a new 510(k) – who's responsible.
  • U.S. FDA device clearance / approval.
  • Using FDA's K97-1 Memo.
  • Tracking and evaluating changes – the “tipping point”.
  • Making the process "risk based".
  • Documenting the process and rationale.
  • Resolving a "wrong" decision .

Who Will Benefit:
All personnel involved in a U.S. FDA-regulated environment especially those involved in new product development, line extensions, and incremental product improvements, having to evaluate those changes to existing FDA-cleared 510(K)'s, and then document their decisions in harmony with regulations:

  • Senior management
  • Regulatory affairs
  • Quality Assurance
  • Production
  • Engineering & R&D

For More Information: