Device Changes, FDA Changes, and the 510(k) - 2019

  • 20 Mar 2019
  • Webinar

Description

Device Changes, FDA Changes, and the 510(k) - 2019 is a webinar focused on

  • 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) - who`s responsible
  • K-97-1 and the FDA`s "Decision Tree"
  • Is the process "risk based"?
  • Resolving a "wrong decision"
  • Documenting the process / rationale

Device Changes, FDA Changes, and the 510(k) - 2019 is intended for:

  • Regulatory affairs
  • Senior management, project leaders, internal / external consultants
  • R&D and engineering staff
  • Quality systems personnel / QAE
  • New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach
  • Personnel involved in Lean and Six Sigma Initiatives
  • CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems

Past Events

Important

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

Event Categories

Business: Innovations, Quality assurance
Government & Global Issues: Law & Regulations

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