Our Regulatory- Clinical team
Qserve understands the additional needs to comply with the regulatory requirements requested by the MDR / IVDR. Qserve can prepare a plan based on your existing data, a practical plan using the solutions provided in the MDR / IVDR.
Our strength is in the combination of Regulatory and Clinical expertise. Starting at the basis of your regulatory strategy we scope together with you the clinical plans. A starting point is your current intended use, risk analysis data, and available as well as planned clinical data.
The regulatory - clinical team is the best partner to support you with a practical clinical plan making use of your existing regulatory approach and data.
Qserve team is able to support from start to end. The support can range from literature search to writing of the CER, to performing the PMCF study. Our clinical team consists of clinical project managers, monitors, and a statistician. The team combines regulatory and clinical writing to prepare the overall report that is needed to show compliance to the Notified Bodies.