Quality system

 

For manufacturers of Medical Devices there is a special quality standard harmonized. The EN ISO 13485:2012 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 requirements and regulatory requirements applicable to medical devices and related services.

Manufacturer of medical devices:
Usually most manufacturers of medium and high risk class devices (Class I+S, I+M, IIa, IIb and III) have a quality system in place. This quality system must be assessed by a Notified Body.

Manufacturer of in vitro diagnostic devices:
Manufacturers of all in vitro diagnostic devices need to have a quality system in place. In case of higher risk products (List A and list B) this quality system must be certified.