In 2011 the European Commission raised a concern around the legal text supporting presumption of conformity to the Medical Device Directives (Annexes ZA, ZB, ZC) in EN ISO 13485:2003. The outcome was that CEN decided to publish a new edition of the standard (EN ISO 13485:2012). This standard has a revised Foreword and Annexes ZA, ZB and ZC, but the core text remains unchanged.
What is BS EN ISO 13485:2012?
BS EN ISO 13485 is a key standard to measure the quality of medical equipment, medical instruments and medical technology. This standard sets out the requirements for a quality management system and quality assurance systems relating to the design, development, production, installation and servicing of medical devices. BS EN ISO 13485 can also be used by internal and external parties, including certification bodies to test an organization’s ability to meet both customer and regulatory requirements.
How does it work?
Specifying the requirements for a quality management system, BS EN ISO 13485 helps organizations to provide medical devices and related services that live up to the expectations of customers and regulatory bodies. Its main objective is to deliver harmonised medical device regulatory requirements, and provide quality management system specifications that complement the technical aspects of related products and services.
Who should buy it?
Organizations dealing with the design, development, production, installation or servicing of medical equipment, devices and technology.
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