• Impact of Adopting ISO13485 in New QMSR for Medical Devices, Part 2

  • Dec 18 2024
  • Length: 29 mins
  • Podcast

Impact of Adopting ISO13485 in New QMSR for Medical Devices, Part 2

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    In this episode of the Quality Grind Podcast, host Mike Kent continues his discussion with Medvacon consultant Armin Beck about the newly amended 21 CFR 820, Quality Management System Regulation for medical devices. The duo explores the implications of new FDA inspection techniques, the importance of thorough gap analyses for readiness, and the increased responsibility of executive management in quality oversight. The lens widens to discuss the potential impact on not just medical device firms but also the broader Life Sciences industry. The episode also offers practical guidance and resources to help organizations align with the new requirements and avoid regulatory pitfalls.

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