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Medical Devices

4 Items

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  1. Themis MDR/IVDR Documentation Guide
    Themis MDR/IVDR Documentation Guide
    Subscription Price €33.32 €28.00 per user
    Subscription details

      An introduction to technical documentation under MDR and IVDR. 
      Includes requirements from the annexes as well as risk classifications for medical devices and IVDs.

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    • Themis Medical Risk Pack
      Themis Medical Risk Pack
      Subscription Price €79.73 €67.00 per user
      Subscription details

        Comprehensive risk management in accordance with ISO 14971. 
        PHA, design, process, and system FMEA, including bidirectional links.

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      • Themis Requirements Pack
        Themis Requirements Pack
        Subscription Price €79.73 €67.00 per user
        Subscription details

          Centralized management of regulatory and technical requirements.
          Includes MDR, IVDR, MDSAP, IEC 60601-1, and Machinery Directive, along with traceability.

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        • Themis Ultimate
          Themis Ultimate
          Subscription Price €223.72 €188.00 per user
          Subscription details

            The complete solution BAYOOSOFT Themis
            Includes all guides and packages for compliance, quality, and risk management.

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