We build EU/UK compliant technical files and provide expert regulatory guidance.
Experts in setting up, maintaining, and stress-testing quality systems.
EU Authorised Representative
Your reliable regulatory partner in the European Union. [EC-REP]
We help importers meet their complex regulatory obligations.
Experts in EUDAMED Actor and UDI-DI registrations.
Our expert team delivers training on various regulatory and quality topics.
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EU IVDR 2017/746
Background In the European Union, the legal manufacturer is understood to be the entity which has the final responsibility for the device being placed on