Assessment of the Quality Management System

Legislation requires a complete quality management system for medical device manufacturers. Compliance with the requirements of ISO 13485 alone is not enough. The regulatory requirements of ISO 13485:2016 include further regulatory requirements for quality management. Depending on market approval, different requirements must be taken into account, e.g. for Europe Regulation (EU) 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnostics, for the US, the U.S. CFR 820 Quality System Regulation or for the approval in Brazil the requirements of ANVISA RDC 16/2013. Each country has its own catalog of requirements that must be transferred to the internal QMS.
Attempts are being made to globally harmonize the regulatory requirements of the various regulatory authorities. This work resulted in the International Medical Device Regulators Forum (IMDRF) defining the Medical Device Single Audit Program (MDSAP). MDSAP describes an audit model that verifies compliance with the requirements of ISO 13485:2016 as well as with the requirements of the participating countries of Australia, Brazil, Canada, Japan and the USA. By participating in MDSAP, you can secure access to multiple countries with just a single audit. The MDSAP audit model provides a detailed requirement catalog for your QMS and describes a uniform and systematic execution of the audit.
Put your quality management on the test bench today and let our experts carry out a detailed analysis according to the regulatory catalog of requirements that applies to you. Get a tailor-made action plan to close any gaps. If you decide to participate in the MDSAP, we will gladly assist you with the preparation and accompany you during your audit as a competent expert at your side