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    • Whitepaper
      Medical Devices

    Developing and Maintaining a Quality Management System for IVDs

    This paper primarily examines the QMS requirements in the new In Vitro Diagnostic Device Regulation (IVDR) 2017/7462.

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    Article 10 (8) of the IVDR establishes a number of requirements.

    This paper primarily examines the QMS requirements

    • QMS Basics

    • Strategy for regulatory compliance

    • Risk management

    • Performance evaluation and postmarket surveillance

    • Unique Device Identification (UDI)

    • Continuous improvement activities

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    Whitepaper

    Unlock Success with a Quality Management System (QMS)

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