arcoro Glossar

DIN EN ISO 13485

The DIN EN ISO 13485 standard deals with the requirements for manufacturing, design and initial provision of medical devices. It forms the basis for many regulatory certification requirements and at the same time the prerequisite for successful international medical device approvals. This globally recognized standard regulates the quality management of medical device manufacturers, suppliers and service providers and, as a result, guarantees the safety of medical devices.

Your contact person

Anne Plonz

Business Analyst

Phone: +4915156319362

Email: plonz@arcoro.de

Field of expertise

Load more news Load less news