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    ISO-13485-blog

    Tag: “Monitoring”

    Calibration requirements in ISO 13485
    Manufacturing medical devices is a highly complex process, and calibration requirements according to ISO 13485 mean high precision and close...
    Manufacturing medical devices is a highly complex process, and calibration requirements according to ISO 13485 mean high precision and close monitoring. The manufacture of medical devices makes use of various types of equipment and measuring...
    How to comply with section 8.2 Monitoring and measurement in ISO 13485:2018
    Monitoring and measurement focus on the quality of the product or services, which reflect the effectiveness of the Quality Management...
    Monitoring and measurement focus on the quality of the product or services, which reflect the effectiveness of the Quality Management System. Simply put, it informs us about whether our products have met the expectations in...