Medical Devices

EU Medical Device Regulation (MDR) Compliance.
EU Medical Devices Directive (MDD) Compliance which will continue to apply for the UK market until Jul 2023.
Preparation of Technical Documentation.
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.

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60 Constitution Street, Edinburgh, EH6 6RR

CHIARA is a member of British In Vitro Diagnostic Association