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QMS implementation and maintenance

Gap Analysis of the QMS against ISO13485 requirements

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Gap Analysis of the QMS against ISO13485 requirements

The Quality Management System Gap Analysis service allows a company operating in the field of medical devices or IVDs to understand whether its QMS documentation complies with the requirements of the UNI CEI EN ISO 13485:2021 standard and what documentary adjustments are necessary if it does not.

The service is useful for all organisations that have an ISO 9001-compliant QMS and need to certify it to the required standards for the medical device and IVD sector.

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