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.