ISO 13485 Accreditation

ISO 13485 Certification

ISO 13485 is an internationally recognised and harmonised Quality Management System (QMS) standard. It is developed for organisations involved in one or more stages of the life-cycle of a medical device and describes a process approach in terms of the design, safety and quality.

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. It is available to all medical device manufacturers as well as industries that support medical device manufacture and those involved in the device supply chain.
It 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 Medical Device Regulation (MDR 2002 as amended).
DEKRA’s audit team consists of experts with extensive skills and expertise to accurately assess the compliance of your management system according to ISO 13485.

Certificate Validation

All certificates of accreditation issued by DEKRA Certification UK Ltd are fully verifiable if they have a UKAS logo. With all certificates now issued digitally we understand the need for verification for acceptance.

UKAS host an independent database for verification of certificates please use the link below to access UKAS CertCheck
For international certificates not accredited by UKAS, IAF Cert Search is available to verify most accreditation certificates.