13485: Medical devices—Quality management systems—Requirements for regulatory purposes, 3ed
This comprehensive and crucial standard dealing with quality management systems (QMS) has been updated for the first time in 13 years in response to the latest developments in quality management, technology, and regulatory requirements related to the medical device industry.
ANSI/AAMI/ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes, is intended to help organizations design a quality management system that establishes and maintains the effectiveness of their processes. This standard is meant to be used throughout a device’s life cycle, from initial concept through post-production, including final decommission and disposal. The updated version of 13485 also covers aspects such as storage, distribution, installation, and servicing, as well as the provision of associated services.
Published: June 2016; 39 pages
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