Preconditions: If you want to market your medical device in Europe or in the US you have to
- compile a technical file proving the compliance of your product with FDA and European regulations and standards such as IEC 62304, ISO 14971, IEC 62366 and IEC 60601-1.
- establish a quality management system compliant with ISO 13485 respectively 21 CFR part 820.
CE Mark = Technical File + Quality Management System
CE-mark and FDA approval: How the Johner Institute helps
Pass CE-approvals and FDA submissions quickly and safely with the Johner Institute's help to compile Technical Files / submission documents including
- medical device software files (e.g. software requirements specifications, software architectures) compliant with FDA and IEC 62304 requirements
- risk management files compliant with ISO 14971
- usability engineering files compliant with FDA and IEC 62366 requirements
- clinical evaluations compliant with FDA and MEDDEV 2.7/1 requirements
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.