Medical Safety Design: Integration of Risk Management and Usability File

The safe and economical use of medical products in diagnostics and therapy require optimal risk management and high usability.
The standards DIN EN 60601-1-6 and EN 62366 oblige manufacturers of medical products to conduct a usability engineering process and risk management that is documented according to standards.

Our services

We assist you from the product idea via the development to the submission of the usability file and risk management file at the notified bodies.

Develop your medical products with us which are fast, safe and intuitive to use. With Medical Safety Design, User Interface Design GmbH (UID) and Jörg Stockhardt consulting & more (c&m) offer you a holistic and unique service.