Device Changes and the 510(k) 2016

  • 15 Mar 2016
  • Webinar

Description

Device Changes and the 510(k) 2016 is a webinar that covers topics such as:

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

Device Changes and the 510(k) 2016 is intended for:

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

Past Events

Important

Please, check "Device Changes and the 510(k)" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Innovations, Internal Audit & Compliance
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Medical technology

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