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occurs Standard DIN EN 62 366 as of March into force

On 21 March 2010 ended the transition period to the standard DIN EN 62 366: The implementation of a usability engineering process and its documentation in a usability File are now required! The new standard applies to all medical devices, such as on medical in-vitro diagnostic medical devices or software.

UID has been preparing for the new requirements: our Medical Service Safey Design we draw on the innovations of the standards and support our customers in the implementation and documentation of measures to usability.

Sun UID developed jointly with Jörg Stock consulting & more complete structure for the Usability Engineering File. This basic structure (it is "macro structure" mentioned), including all of the standard required individual documents. These separate documents are present contents (as it were, the "microstructure") that all required content in the right place can be placed. The certifier can thus keep track of the entire usability process that was undertaken in the development of the medical device effortlessly. In addition, the macro structure visualizes the chronological sequence of generating the necessary documentation and the timing of of measures to improve / establish the suitability for use (eg usability validation) in the development process.

There are already medical devices in the market, presented their entry into a document created by this structure, usability engineering file with a Notified Body.