This document is the collection of records that provide evidence of the device usability validation activities. The documents included are:
– Usability Report EN 62366-1
– Usability Engineering File
– Usability Summative Evaluation
Available Languages: English
The information contained on this page and in the documents referred to is valid and current as of 07/17/23. Legislative and regulatory provisions are subjec to change and updating by the Regulatory Authorities. This being said, the writer declines all responsibility for any possible lack of topicality and/or accuracy of the information that may have occurred at the same time as or following the publication of this page and the documents referred to. Disclaimer
