Ready to use prioritized ISO 13485 requirements, to:

Monitor key quality system metrics, process indicators, and overall health of the cGMP Quality Management System (QMS) to proactively identify and address quality systems or product issues and ensure its continuing stability, effectiveness, and improvement. .


    • Does your organization have documented procedures to control design and development changes?
    • Does the manufacturer have documented procedures for traceability for all Class III and IV devices that meet the ISO definition of implantable medical device or active implantable medical device?
    • Do manufacturers who use suppliers to provide finished medical devices have documented procedures in place to ensure that the finished medical device is safe and effective?
    • What will employees need to do for the ISO 13485 Quality Management System?
    • How many design reviews does your medical device product development project need?
    • How do you maintain the effectiveness of the Quality Management System in accordance with ISO 13485 requirements?
    • Does the organization have the documented procedures required by ISO 13485 and 21 CFR 820?
    • Are procedures in place that define the content, location and retention of quality system records and process control records, and are records of compliance available?
    • How does your organization control the purchasing processes to ensure that purchased product conforms to specified purchase requirements?
    • How do you implement MDSAP into an quality management system according to ISO 13485, 21 CFR 820 (QSR) or any other regulatory framework?

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