In Vitro Diagnostic Medical Devices

EU In Vitro Diagnostic Medical Device Regulation (IVDR) Compliance.
EU In Vitro Diagnostic Medical Device Directive (IVDD) Compliance which will continue to apply for the UK market until Jul 2023.
Preparation of Technical Documentation.
Generation of performance evaluation protocols and reports.
Design Control.
Labelling consistency and accuracy.
Usability requirements.
Registration in global markets.

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Contact

60 Constitution Street, Edinburgh, EH6 6RR

CHIARA is a member of British In Vitro Diagnostic Association