Usability and Human Factors = Medical Safety Design:
Integration of Risk Management and Usability File

Safe and economic use of medical devices in diagnosis and therapy in daily work needs a well installed Risk Management Process in product design and perfect Usability of the device.

This practicability and safety in use of the device shall not be detected till use in the market (as bananas do!). It shall be taken into consideration from the very start of product development process and is to be proven by evidence in the Conformity Assessment Process.

The manufacturers of medical devices and in-vitro-diagnostic medical devices are forced by the harmonized standards EN 60601-1-6 and EN 62366 to implement and document a Usability Engineering and Risk Management Process in conformity to the standards.

What are we doing?

Starting with Product Idea, over the whole Development Process until review of the Usability File and Risk Management File by the Notified Body we will assist you with our experience and expertise.

Carry out the design of new medical devices together with us to assure fast, safe and intuitive usable devices. Medical Safety Design a service of Jörg Stockhardt  consulting & more and User Interface Design GmbH serves You with a complete and unique concept.

You need further information? Take a look in our Medical Safety Design Homepage!