Medical Devices Newsletter - Issue 41

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In this issue

  • Letter from the editor 1
  • Regulatory Science Ireland – working together for better patient outcomes
  • The Medical Device Single Audit Programme (MDSAP) – a global approach to quality management system auditing.
  • HPRA Communications
  • Proposals for new regulation on medical devices and in vitro diagnostic medical devices – state of play
  • Regulatory Updates
    • Clinical Investigation and Evaluation (CIE) Working Group
    • New and Emerging Technologies
    • (NET) Working Group
    • Medical Device Expert Group (MDEG) - Vigilance
    • Working Group on Qualification and Classification of Software
    • Compliance and Enforcement (COEN) Working Group
    • CAMD
    • The IMDRF Management Committee Meeting

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