In Vitro Diagnostic Medical Devices

  • EU In Vitro Diagnostic Medical Device Regulation (IVDR) Compliance.

  • EU In Vitro Diagnostic Medical Device Directive (IVDD) Compliance.

  • Preparation of Technical Files/Design Dossiers.

  • Generation of performance evaluation protocols and reports.

  • Design Control.

  • Labelling consistency and accuracy.

  • Usability requirements.

  • Registration in global markets.