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ISO 13485

ISO 13485

ISO 13485 quality management system certification provides a basis for compliance to worldwide medical device regulations.

DEKRA ISO13485 surgery medical devices

Based on ISO 9001:2008, ISO 13485:2016 expands on the provisions in ISO 9001 to further detail requirements such as work environments, regulation & vigilance, and specifics to the medical device industry. With published EN and BS versions of the standard ISO 13485 is harmonized to both the MDR/IVDR and UK MDR 2002.

In order to ensure consistent quality of medical devices and related services, manufacturers across the medical device supply chain need to fulfil the certain requirements, which are largely captured in the ISO 13485 standard. ISO 13485 management system certification demonstrates that a manufacturer has designed and implemented robust processes for the development, production, design, and servicing of medical devices and in vitro diagnostic medical devices.

ISO 13485 is applicable to all medical device manufacturers and industries that support medical device manufacture, such as component manufacturers, transport and service provision. Many potential customers use ISO13485 certification as a prerequisite to supply, meaning certification gives you the ability to access markets previously unavailable.

DEKRA UK is committed to the highest standards of certification and are in process to be accredited by UKAS as a certification body for ISO 13485 & ISO 9001.

Our UK team of medical device experts work closely with our customers to ensure we deliver a valuable audit service for both ISO 13485:2016 & integrated ISO 9001:2015 certification.

Contact

DEKRA Certification UK Limited 

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