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.