• 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.

Delivering with clarity – your partner in regulatory compliance.

Contact

✉  lesleypaice@chiara-raqa.com

☎ 07909 983 485

 

60 Constitution Street, Edinburgh, EH6 6RR

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