Legal Representative Services

 

The sponsor of a clinical investigation - who is not established in the EU - has to appoint a natural or legal person inside the EU as his 'Legal Representative'. As professional full service provider (with medical and clinical expertises in house) we're looking forward to act for you as 'Legal Representative' as defined in Article 50 of the MDR. Doing this we are responsible for ensuring your compliance with the obligations as defined in the new Medical Device Regulations (MDR). Any communication via the 'Legal Representative' shall be seen as communication with you as sponsor.

Please contact our office for more information: This email address is being protected from spambots. You need JavaScript enabled to view it.

News

  • ‘Person Responsible for Regulatory Compliance’ (MDR: Article 15)
    [acronyms as QP (Qualified Person) and or CO (Compliance Officer) and or LP (Legal Person)] As recognised independent professional service provider we’ve developed (A) QP or CO services for SME organizations or manufacturers;  and (B) QP or CO Training Program. Our ‘Person for Regulatory Compliance’ holds an university degree in…

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