These main documents are:
- Checklist of the documents with shall be included in the full Technical Documentation
- Checklist of the documents that we need to keep in our European office for allowing us to present to Competent Authorities upon request
- General Safety and Performance REequirement list. The manufacturer has to answer with reference to standards and to the titles of their internal procedures
- Template of Post-Market Surveillance Plan (PMS).
- PMSR and PSUR templates
- Symbols for multilingual labeling
- Models of EU declarations of Conformity
- ETC .. . .