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    • Brochure
      Medical Devices

    ISO 13485 Quality Management System (QMS)

    Your pathway to QMS certification.

    Read the Brochure

    Discover BSI ISO 13485 assessment process

    Adopting ISO 13485 strengthens trust across the supply chain, from manufacturers to distributors, while enhancing global marketability.

    • The key steps involved in achieving ISO 13485 certification and what to expect at each stage.

    • Practical guidance on how to prepare effectively for your Stage 1 assessment.

    • Insights into what Stage 2 assessment entails and how to demonstrate readiness.

    • An overview of the ISO 13485 certification cycle, along with best practice tips from BSI experts.

    Insights & Media

    Learn from global experts in healthcare standards

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    Let's shape your organization's future together

    Reach out and see how we can help guide you on your path to sustainable operational success.

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