ISO 13485 is a harmonized standard for compliance in the manufacture and marketing of medical devices.
Any organization that manufactures and/or markets medical devices under its name in the European Economic Area must comply with the European Directives (90/385/EEC, 98/79/EC and 93/42/EEC). The organization must prove this by means of a conformity assessment procedure. The introduction of a quality management system is required here, which is also the basis for certification according to ISO 13485.
We would be happy to support and advise you on setting up, optimizing and maintaining your quality management system in accordance with ISO 13485.