ISO 13485:2016, Third Edition: Medical devices - Quality

ISO 13485:2016, Third Edition: Medical devices - Quality management systems - Requirements for regulatory purposes

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.
Country USA
Manufacturer Multiple. Distributed through American National Standards Institute (ANSI)
Binding Paperback
ItemPartNumber 926710702X
ReleaseDate 2016-03-01
EANs 9789267107028

Country	USA
Manufacturer	Multiple. Distributed through American National Standards Institute (ANSI)
Binding	Paperback
ItemPartNumber	926710702X
ReleaseDate	2016-03-01
EANs	9789267107028

ISO 13485:2016, Third Edition: Medical devices - Quality management systems - Requirements for regulatory purposes