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