Regulatory Affairs

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Regulations may not be desired, but they are inevitable and must be implemented, sooner or later. We have extensive experience in regulatory affairs for IVDR and MDR requirements. Let us assist you in navigating and complying with these regulations. 

The new regulations for IVDs and Medical Device also require a robust QM-System to demonstrate compliance. 

We provide support for IVDR implementation including documentation, clinical study support and project management as well as PRRC role (applies only to SME).

We provide expertise in TD files according to IVD Class A, Class A Sterile, Class B, Class C & Class D including Near-Patient Testing & Self Testing in German and English.

We have a proven track record in implementing IVDR and MDR projects, obtaining QM-System and Product Certificates. Let us assist you in achieving your goals smoothly and safely by providing shortcuts and risk mitigation strategies.