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In-vitro Diagnostic Regulation (IVDR) Services

MakroCare experts guide you on how to systematically review your technical documentation and QMS ahead of GAP assessments for EU In Vitro Diagnostic Regulation (IVDR) implementation debates.

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CE Certification Consultants for Medical & IVDs Devices

We provide CE certification consultancy services to obtain CE marking for your products under the EU MDR 2017/745 and EU IVDR 2017/746 regulations.