ADAX can support you to compile a regulatory compliant Medical Device Technical Documentation and ensure your company achieves CE Marking certification.
- Compile your EU Technical Documentation or Design Dossier.
- Help you determine exactly which documents need to be assembled.
- Completely review all existing documentation in support of meeting the applicable Essential Requirements of the Regulation(s).
- Determine applicable standards for your device.
- Review your clinical data, compile a Clinical Evaluation Report (CER).
- Review your proposed labeling and Instructions for Use.
Read more in our Publication: Medical Device - Technical Documentation