Medical

Devices

  • EU Medical Device Regulation (MDR) Compliance.

  • EU Medical Devices Directive (MDD) Compliance.

  • Preparation of Technical Files/Design Dossiers.

  • Reviewing Clinical Evaluation Reports against the requirements of MEDDEV 2.7/1.

  • Post-market Clinical Follow Up Requirements against the requirements of MEDDEV 2.12/2.

  • Clinical Studies.

  • Biocompatibility requirements.

  • Design Control.

  • Labelling consistency and accuracy.

  • Post-market Clinical Follow Up Requirements against the requirements of MEDDEV 2.12/2.

  • Usability requirements.

  • Registration in global markets.