ISO 13485 Medical Devices

ISO 13485 Medical Devices

The world's most recognised medical device standard helps organisations of all sizes.

The world's most recognised medical device standard helps organisations of all sizes.

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Gain the market confidence you need to reach your goals.

BSI employs over 150 medical device experts with experience in all aspects of the product life cycle including research and development, manufacturing, and quality assurance.

Mitigate future risk and manage compliance – especially as your position in the global market shifts. BSI has multilateral agreements with many countries so that our test reports for a wide range of products can be accepted.


What are the benefits of ISO 13485 Medical Devices?

  • Increase access to more markets worldwide with ISO 13485 certification
  • Outline how to review and improve processes across your organisation
  • Increase efficiency, reduce costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations

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