Given that we market in the United States and in Europe, and maintain an EN ISO 13485:2016 quality system, we have the following documentation requirements for each project:
Input much appreciated!
- A "Medical Device File" (as required by EN ISO 13485:2016, 4.2.3)
- A "Technical File/Design Dossier" (for CE Marking)
- A "Device Master Record" (as required by 21 FDA CFR §820.181)
Input much appreciated!