IMPORTANCE OF ISO 13485 FOR QUALITY MANAGEMENT OF MEDICAL DEVICES



  • ISO 13485 standard provides a framework for the manufacturers, retailers or distributors of medical devices to ensure the quality and safety of their products. It helps in addressing all the related regulations and demonstrating commitment to the safety and quality of medical devices.

    ISO 13485:2016 Background

    The latest version of ISO 13485 Certification was introduced in 2016 and the organizations were expected to upgrade to it in the next three years. The key objective for upgrading the standard was to meet the global market standards. This version also integrates the key elements from the global audit model MDSAP (the IMDRF Medical Device Single Audit program) as well as that of the EU Medical Device Regulations (EU-MDR). The new version takes into consideration, the following aspects:

    • Increased compliance with various regulations.
    • Increased requirements for design and development that involves considerations of usability and maintenance of records.
    • Better controls for outsourced processes and suppliers
    • Increased requirements for process validation
    • The requirements for “feedback” help in better handling of complaints.
    • Data analysis through various statistical techniques.


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