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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

Our Quality Management System (QMS) Gap Analysis service helps companies in the medical device and IVD sectors understand if their QMS documentation complies with the UNI CEI EN ISO 13485:2021 standard. If your documentation falls short, we identify the necessary adjustments to achieve full compliance.

This service is invaluable for organizations with an ISO 9001-compliant QMS that need to meet the specific certification standards required for the medical device and IVD industries.

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