Medical Device Certification
Assessment and certification services for the medical device industry
As a medical device manufacturer, you must navigate your way through a complex landscape of regulatory requirements before you can sell your devices on the international market. International standards and European regulations are there to ensure that products are safe and function accordingly.
Why DEKRA for Medical Device Regulatory Services
- MDR / IVDR: Two European Notified Bodies: DEKRA Certification GmbH (NB 0124) and DEKRA Certification B.V. (NB 0344) to provide services to companies involved in the design, manufacturing, and distribution of medical devices.
- UKCA: Designated Approved body (8505) in the UK to provide UKCA certification under Medical Device Regulation (MDR 2002 as amended, Part II).
- ISO 13485: ISO 13485 is an internationally recognized and harmonized Quality Management System (QMS) standard. It is developed for organizations involved in one or more stages of the lifecycle of a medical device and describes a process approach in terms of the design, safety and quality.
- MDSAP: The Medical Device Single Audit Program (MDSAP) is built on ISO 13485, incorporating additional requirements from regulatory authorities participating in the program. The initiative aims to enhance efficiency and safety through increased consistency. Compliance is mandatory for placing products on the market in Canada and facilitates market entry for Australia, Brazil, Japan, and the USA.
- Technical Cooperation Program (TCP): The Technical Cooperation Program (TCP) enables the exchange of regulatory audit reports for medical device Quality Management Systems (QMS) in accordance with Good Manufacturing Practice (GMP) and ISO 13485. This exchange occurs between EU Notified Body Partners and medical device QMS auditing organizations authorized by the Taiwan Food and Drug Administration (TFDA).