In Vitro Diagnostic Medical Devices
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EU In Vitro Diagnostic Medical Device Regulation (IVDR) Compliance.
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EU In Vitro Diagnostic Medical Device Directive (IVDD) Compliance.
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Preparation of Technical Files/Design Dossiers.
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Generation of performance evaluation protocols and reports.
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Design Control.
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Labelling consistency and accuracy.
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Usability requirements.
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Registration in global markets.