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ISO 13485 Quality Management System Audits

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Medical Device Certification ISO 13485 | Eurofins E&E

In addition to product compliance, medical device manufacturers have to provide evidence that they have fulfilled the requirements of ISO 13485; a process-oriented, medical device industry-specific, Quality Management System (QMS) standard.

ISO 13485 is a harmonized standard for the directive 93/42/EEC.

Eurofins Medical Device Testing operates as accredited Certification Bodies according to ISO 13485 Quality Management System for Medical Devices. The ISO 13485 is recognized for the quality management systems in the medical devices sector, intended to be used by any organization that deals with the design, development, production, installation and technical assistance of medical devices or services connected to them.

This certification helps the applicant to demonstrate their commitment to the quality management system. It shows responsibility by the company supplying the medical device product or service to conform with the rules; linked through compliance to the applicable standards and customer experience.

ISO 13485:2016 supersedes ISO 13485:2003/Cor 1:2009 and carries with it a number of changes. The transition period ends on 1st March 2019.

Choose Eurofins Medical Device Testing to help you:

      ✔  Obtain your ISO 13485 QMS certification through our audit and inspection services.
      ✔  Maintain your ISO 13485 QMS certification.

Certification Bodies:

Eurofins Medical Device testing services operate as Certification Bodies D-ZM-12092-01-00 (Germany), n. 133A (Italy) and n. S021 (Finland) according to ISO 13485 Scheme; Quality Management System (QMS) for Medical Devices.

These certification bodies’ services are through our global network of Eurofins Electrical & Electronics (E&E) laboratories.