SS-EN ISO 13485:2016
Current
The latest, up-to-date edition.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Hardcopy
Swedish - English
07-03-2016
This International Standard 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.
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.