ISO13485 - Manufacturing medical devices -from design to mass production

Nissha group has a total of 11 medical device manufacturing sites, starting with our Kyoto factory in Japan, as well as locations in North America, Central and South America, Europe, and Asia.

ISO13485 (Medical Device Quality Management System)

ISO 13485 is an international standard for quality management systems that is specialized for medical devices. It sets stringent quality standards and certifies a reliable quality management system in the development and manufacturing of medical devices.

Features of ISO13485

ISO 13485 is an international standard for quality management systems that is based on the content of ISO 9001, with the aim of ensuring quality and safety in relation to medical devices.

The number of countries requiring ISO 13485 certification for medical devices is increasing. Therefore, we think that it is an important certification for the overseas manufacturing and export of medical devices.