InfoSec Insider

ISO 13485 Explained

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In this episode of InfoSec Insider, Stuart Moran, Senior Consultant at URM, offers essential advice on ISO 13485, the International Standard for Medical Devices Quality Management Systems (MDQMS).  Stuart draws upon over 20 years of experience in managing organisation-wide management systems to discuss:

  • What ISO 13485 is and why it’s important for regulatory compliance
  • Which organisations ISO 13485 is applicable to, including medical device manufacturers and their suppliers
  • When you should consider implementing ISO 13485
  • How and why ISO 13485 differs from other management system standards you may have implemented
  • Aligning and integrating other ISO standards activities and documentation with ISO 13485 requirements
  • Whether the current, very significant changes to US federal agencies will impact the Food and Drug Administration’s (FDA’s) move to align their regulation with ISO 13485.

    • Learn more about this topic: https://www.urmconsulting.com/blog/iso-13485-medical-devices-quality-management-system-explained

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