The regulatory requirements regarding Clinical Evaluation have become more strict and prescriptive under the MEDDEV 2.7.1/ rev 4 and the new Medical device regulation in the EU. Updates of medical device requirements in the US (510k de novo) and China will increase the scrutiny of international regulatory authorities regarding Clinical Evaluation of medical devices.
One of the main changes is that the application of the principle of equivalence will be limited. When selecting an equivalent device for clinical regulatory strategy, a manufacturer is expected to have access to key technical documentation regarding the equivalent device.
Qserve expects that during the medical device product lifecycle Clinical Evaluation will more frequently involve the collection of new clinical data for market approval and post market clinical follow-up.
For this reason, Qserve has currently extended its capabilities in execution of clinical investigations. Individual members of the Qserve clinical team have extensive experience in CRO functions. Furthermore, broad expertise of Qserve enables us to carefully assess the applicable requirements and to define an optimal and tailored strategy to develop a medical device, and where needed execute well designed clinical trials to enable market approval.
Our CRO activities include project management, clinical documentation, regulatory submissions, site monitoring, and final data analysis and reporting.
We look forward to supporting you in developing clinical investigation strategies for your medical device, using existing and newly collected clinical data.
Qserve's Clinical Team
Wiebe, Peter, Loes and Anna