Preconditions: If you want to market your medical device in Europe or in the US you have to
CE Mark = Technical File + Quality Management System
Pass CE-approvals and FDA submissions quickly and safely with the Johner Institute's help to compile Technical Files / submission documents including
With the support of Johner Institute you will establish Quality Management Systems compliant with FDA's 21 CFR part 820 and with ISO 13485 — a precondition for the European CE-marking.
The usability experts of Johner Institute will not only help you to compile usability files, but also to recruit participants as well as to plan and to perform usability tests in the US and in Europe.