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.

Increased regulatory requirements affecting organizations across the medical device supply chain necessitated a broadening of the standard’s application to encompass organizations involved in design and development or repair and maintenance of medical devices; supply of raw materials, components, or subassemblies; performance of services, such as sterilization, logistics, or calibration of measurement equipment; and the importation or distribution of medical devices.

Published: June 2016; 39 pages

Product CodeFormatList PriceMember Price
13485 Print $222 $131
13485-PDF PDF $222 $131
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