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
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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