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. ISO 13485 is harmonised standard for EU MDR/IVDR and designated standard for UK MDR 2002 (as amended).
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 available to all medical device manufacturers as well as industries that support medical device manufacture and those involved in the device supply chain. Although not a pre-requisite for placing a product on the market, ISO 13485 is a globally recognised standard that provides the framework for medical device quality management systems. It also provides a basis for the design, manufacture and production of products that meets the requirements of many regulatory schemes such as the UK MDR 2002.
DEKRA UK is committed to the highest standards of certification and has UKAS accreditation 23158 in accordance with ISO 17021-1 to be certification body for ISO 13485.
Our UK team of medical device experts work closely with our customers to ensure we deliver a valuable audit service for ISO 13485:2016 certification.