EN ISO 13485 concerns organizations involved in one or more stages of the life cycle of a medical device, such as:
- design
- manufacture
- installation
- maintenance
- marketing
- storage
- technical support
- scientific support
- repackaging
- education
Key points of the standard are the risk approach for the design and implementation of the product, the validation of the procedures, the compliance with legal and regulatory requirements, the ongoing training of company staff and the existence of traceability and recall procedures with reference to the relevant principles.
It is an internationally recognized standard of quality and safety for the manufacture of medical devices while the certification according to ISO 13485 helps companies, through better control of their processes, to continuously improve and strengthen their position in international and local markets.
EN ISO 13485: 2016 is the pre-eminent standard for a manufacturer of medical devices to comply with the instructions of the Regulation (EU) MDR 2017/745.
