ISO 13485 Certification
ISO 13485 quality management system certification provides a basis for compliance to worldwide medical device regulations.
Details
Medical Device Services
As a medical device manufacturer, you must navigate your way through a complex landscape of regulatory requirements before you can place your devices on the market. International standards, UK and European regulations are there to ensure that products are safe and function accordingly.
DEKRA is active almost everywhere in the world and the members of our medical device team have extensive expertise in a wide array of medical and in vitro diagnostic devices.
- UKCA conformity assessment as a UK Approved Body (8505) for the Medical Device Regulation (MDR 2002 as amended).
- ISO 13485:2016 quality management system audits as a UKAS accredited Certification Body (23158).
- Access to the DEKRA global network of offices and state-of-the-art laboratories. DEKRA are able provide services and certifications that are needed for a worldwide market access. For medical devices this includes Europe (CE certification), Australia, Brazil, Canada, Japan and the USA (Under MDSAP certification), Singapore and Taiwan.