EU MDR/IVDR Team

While the Medical Device Regulation (MDR) may appear overwhelming to many manufacturers of medical devices, our expanding team specializes in alleviating these concerns and offering guidance through the regulatory landscape. As a reliable partner, we can intervene at any stage of the medical device lifecycle, offering advice and support. This encompasses initiating Clinical Evaluations, managing Risks, fulfilling Requirements Engineering, obtaining Approvals, conducting Verification & Validation, ensuring Software Quality, and concluding with Post-Market Surveillance.

Our utmost priority is to meet your company’s requirements in the most effective manner possible, providing you with a dedicated expert who aligns with your specific needs and those of your company.