Qserve, as expert medical device regulatory consultants, have considerable in-house competence, and access to a large network of experts, in the area of pre-clinical studies.

Global Medical Device Regulations require that a product:

• Demonstrates compliance with the Essential Requirements of performance and safety.
• That this demonstration of compliance Is supported by pre-clinical and clinical evidence that is appropriate for its intended use.

Pre-clinical studies

Pre-clinical studies, non-human assessments, are performed to evaluate the safety and effectiveness of a (prototype) medical device prior to its admittance to clinical trials. These studies include:

• Electrical safety tests ( to ensure that the device is safe during use and is not sensitive to electromagnetic fields or does not emit electromagnetic radiation above the accepted limits);
• Biocompatibility tests ( to ensure that the device does not produce a toxic or immunocological response in living tissue, related to leachables, impurities or metabolites contained in the device; most of these biocompatibility tests are in vitro, e.g., sensitivity, specificity, interference and assay performance;
• Physical and mechanical tests (to predict the adequacy of device response to physiological stress, harsh environments, forces and (long-term) use);
• Animal studies (which may include device manipulation and handling studies, performance and pathology information);
• Stability/ shelf life testing;
• Sterilization validation tests.

Qserve Consultancy can advise you on all types of pre-clinical testing. The “test early and test purposefully” strategy is the approach taken by Qserve’s team of experts to pre-clinical studies; it is the one most likely to advance your medical device quickly towards a successful regulatory submission.

Clinical Studies

The validation of the design process ends with the clinical evaluation of the device in the proper environment, in relation to its intended use. This evaluation might be based upon a literature review or on an own clinical investigation. For example, devices based on existing technology and intended for an established and accepted use may be able to rely solely on clinical data obtained from a literature review on a similar or “equivalent” device. If such literature data is not available a clinical investigation has to be performed. The level and nature of data to be obtained from a clinical study will be commensurate with the intended use of the medical device and with the degree of novel technology and/or novel applications incorporated in the device. More novel devices will require a comprehensive clinical study before they can be admitted to the market. Whatever the device type, Qserve can identify and advise you on the appropriate clinical study requirements for your device.

Once your device has been admitted to the market, a post market clinical follow-up(PMCF) is a requirement for high risk devices. Such a plan should accompany the clinical evaluation report .

Qserve (pre) clinical studies deliverables include:

• Selection of suitable physical testing. If required, the sourcing of a laboratory to carry out this work.
• Biocompatibility and safety studies
• Selection and set up of suitable simulation models or animal performance studies to evaluate the clinical performance of a medical device. We can also help you with the selection of an appropriate site for the performance of such studies.
• Shelf life study protocols.
• Identification of “equivalent” devices.
• Conducting, writing and reviewing clinical literature studies.
• Preparation of clinical study materials: strategy, advice on, and review of clinical investigation plans and clinical study protocols, investigators brochures, etc.
• Post market clinical follow-up (PMCF): preparation of plans and protocols.
• Selection of Clinical Research Organizations and Agencies (CRO’s & CRA’s).