ISO 13485 - Medical device manufacturers
ISO 13485 specifies requirements for a quality management system that can be applied by an organisation for the design and development, production and installation as well as the maintenance of medical devices.
ISO 13485 - Medical device manufacturers
ISO 13485 specifies requirements for a quality management system that can be applied by an organisation for the design and development, production and installation as well as the maintenance of medical devices.
Summary
The standard is aimed at organisations that must comply with one of the European directives for medical devices (90/385/EEC, 93/42/EEC, new (EU) 2017/745 and 98/79/EC, new (EU) 2017/746) in order to affix the CE mark to their products, and other parties involved in the development, manufacture and marketing of medical devices.
For medical device manufacturers, ISO 13485 is therefore the necessary addition to their management system in accordance with ISO 9001.
It should be noted that the requirements for the quality management system specified in this international standard apply in addition to the technical requirements for products.