Expertise Field

International support with Clinical Studies and Clinical Evaluation

  

There is a worldwide trend towards more emphasis on clinical data for regulatory submissions. With the new MDR/IVDR the notified bodies will ask for more and more clinical data. The experience is that there is more emphasis on clinical proof of claims & intended use. Customers need to proof to Notified Bodies the underlying data, risk analysis, and rationales.

Services

What we can do for you?

 

Clinical Evaluation

Qserve supports medical device manufacturers with their Clinical Evaluation during distinct phases of product development, underpinned by risk management activities.  

Medical Device CRO

We provide  study designs and, investigational plans, and aid in institutional review board and regulatory submission processes.    

Post-market Clinical Follow-Up

We offer a post-market surveillance strategy that fulfills regulatory requirements and enables product innovation.  

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.