Most recent
OVE/ONORM EN ISO 13485:2022
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
This International Standard specifies requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable legal requirements. Such organisations may be involved in one or more stages of the life cycle of a medical device, including the development, production, storage and distribution, installation or maintenance of a medical device and the development or provision of related activities (e.B. technical support). This International Standard may also be applied by suppliers or external parties who provide products, including services related to the quality management system, to such organisations. Requirements of this International Standard are applicable to organizations, regardless of their size and ...
Content Provider
Austrian Standards Institute [on]
