Clinical Evaluation

Clinical Evaluation is the final validation of a medical device to confirm that the device performs as intended and can safely be used in patients in accordance with its instructions for use.

Worldwide regulatory requirements prescribe how such Clinical Evaluation needs to be completed. Specific regulatory requirements regarding Clinical Evaluation exist for example, in the US, EU, and China. Key principles of Clinical Evaluation are the same in the different regulatory regions.


Scoping the clinical evaluation

The specific regulatory requirements to be addressed as well as the relevant clinical research question(s) need to be identified in a Clinical Evaluation plan or strategy.

From there a review of existing clinical data is performed to establish if additional clinical data need to be generated to address the clinical research questions through the gathering of new clinical data (i.e., a clinical investigation).

Qserve has experts (many of whom were former regulators) who are very familiar with identifying the correct regulatory requirements to be addressed, as well as developing an appropriate research question(s) required to fulfill the regulatory requirements.

Literature Review

The evaluation of existing clinical data regarding a medical device is essential in understanding the benefit and risk determination of a medical device. Clinical literature- and safety data available in the public domain are assessed and reported on.

Review of clinical literature data is key estimate baseline risk associated with the device, and to identify potential knowledge gaps that will need to be addressed during the Clinical Evaluation, possibly including clinical investigation of a medical device.

Qserve has a dedicated staff with key competences in setting the objectives and scope for a literature review. In case there are no gaps the Clinical Evaluation can be completed based on existing clinical data only and no additional clinical data is necessary.

Clinical Investigation

If the Clinical Evaluation Strategy identifies the need to collect new (additional) clinical data, Qserve can continue to perform the clinical investigation on behalf of the manufacturer.

We offer support in the following areas:

Clinical Evaluation Report
Our evaluation of clinical data establishes the safety and performance of your device.

Clinical Strategy
Study design, global registration requirements, sample size.

Post Market Clinical Follow-up
Development of a post-market surveillance strategy that fulfills regulatory requirements and enables product innovation.

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

Literature Review
Qserve uses literature to assess clinical and scientific data that is relevant to your medical device and its intended use.

Data Management & Statistics
Managing clinical data and statistical analysis.

Medical writing
Protocol, ICF, IB writing.

Clinical Project Management
Adequate and tailored clinical study management will result in a positive return on investment.

Clinical Trial Monitoring
On-site (initiation, interim, close-out), remote, risk-based

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