BS EN ISO 13485:2012 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
- British Standards Institution (BSI)
BS EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes 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. It 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.
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.
|Format||Paperback||Published||31 Mar 2012|
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