Clinical Evaluation, Full-Service CRO, and Post-Market Clinical Follow-up for Medical Devices.
A practical approach for clinical data.
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.
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 on 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.
"With over 15 years of experience in medical device development, both in the pre-market and post-market setting, I know what it takes to effectively plan and execute clinical trials. I have reviewed many clinical evaluations and clinical trial results as a former notified body reviewer. I consider my broad knowledge and experience in both regulatory and clinical fields essential in clinical strategy decision making. Plotting a successful clinical strategy together with a client is probably the most satisfying part of my job."
Qserve supports medical device manufacturers with their Clinical Evaluation during distinct phases of product development, underpinned by risk management activities.
We provide study designs and, investigational plans, and aid in institutional review board and regulatory submission processes.
We offer a post-market surveillance strategy that fulfills regulatory requirements and enables product innovation.
Our evaluation of clinical data establishes the safety and performance of your device.
Qserve uses literature to assess clinical data that is relevant to your medical device and its intended use.
Qserve offers clinical site training, initiation, clinical study monitoring, and data verification.
A good match when selecting a clinical site will support the acceptability of your CIP.
This blog looks at the impact of the new regulation on clinical studies you already performed, and clinical data you collected under the MDD, and challenges everyone’s decision to not perform additional clinical trials or PMCF studies.