ISO 13485:2016 - QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES
Certification of a quality management system specific to medical devices in accordance with ISO 13485 is advantageous and, in many cases, essential for companies exporting their products to the global market.
WHAT IS AN ISO 13485 QUALITY MANAGEMENT SYSTEM?
The international standard UNI EN ISO 13485:2016 concerns the medical device sector and specifies the requirements for the quality management system of organizations involved both in the design and production of medical devices and in the design and provision of related services.
THE UNI EN ISO 13485 STANDARD APPLIES TO:
- Manufacturers of devices subject to CE marking (all medical device classes)
- Suppliers of special processes associated with device production (sterilization, storage, transport)
- Companies that distribute and commercialize medical products
- Companies providing services related to devices (installation, maintenance and repair, clinical engineering)
WHAT ARE THE BENEFITS OF ISO 13485 CERTIFICATION?
- For medical device manufacturers, EN ISO 13485 certification provides a presumption of conformity of the quality system in the assessment of requirements for CE marking conducted by a Notified Body
- For manufacturers of Class I medical devices (self-declaration), EN ISO 13485 certification allows a direct and independent verification of activities and serves as a preliminary step to possible market surveillance activities carried out by the Ministry of Health
- For companies that distribute or commercialize medical products and for companies providing services related to devices, UNI EN ISO 13485 certification enables participation in public procurement tenders issued by public administrations