ADAX can support you to compile a regulatory compliant Medical Device Technical Documentation and ensure your company achieves CE Marking certification.

We can:

  • 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