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

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


Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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