Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices 2015

  • 21 Jul 2015
  • Webinar

Description

Topics
  • Test selection of the ISO standard
  • Background of the new draft guidance
  • General biocompatibility testing considerations
  • Test selection as per the FDA modified matrix
  • Labeling
  • Test specific considerations
  • Examples
  • Test Reports
  • Comparison of the draft guidance with the 1995 memorandum
Who should Attend
  • Project managers
  • Regulatory managers
  • Product development managers
  • Staff involved with regulatory filings

Past Events

Important

Please, check "Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Science: Life Sciences & Biology

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