Monday, 25 February 2019

Medical device QMS harmonisation


The US FDA has made a formal announcement of its intention to replace certain aspects of the existing Quality System Regulation (QSR) with specifications of the international consensus standard ISO 13485:2016. This change is currently at the proposed rule stage.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

In relation to this, Tim Sandle has written an article:


Sandle, T. (2018) Medical device QMS harmonisation: FDA to align with ISO 13485, GMP Review, 17 (3): 4-8

For details, please contact Tim Sandle

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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