In order for your medical devices to be approved in important markets, proven quality management for the design and manufacture of your product is essential. For this, EN ISO 13485 sets requirements for regulatory purposes.
Accordingly, the standard deals with requirements that you as a manufacturer must fulfil in order to meet the quality requirements in the development and implementation of management systems for medical devices. EN ISO 13485 was first developed in 1996.
In the meantime, several standards have been combined under it, including ISO 13488. Certification according to ISO 13485 is carried out by accredited certification bodies, such as DQS or TÜV.