The Clariscience team’s cross-disciplinary, scientific/clinical and regulatory expertise is also available to assist the customer in conducting performance evaluations of IVDs, in accordance with the requirements of the In Vitro Diagnostic Devices Regulation (IVDR, 2017/746), and thus prepare Performance Evaluation Plans (PEPs) and Performance Evaluation Reports (PERs).
The team is also available for the independent verification of already conducted performance evaluations (IVDs), as well as for the elaboration of specific scientific/clinical rationale for regulatory purposes, and for carrying out only some of the activities related to performance evaluations, such as literature searches, or others.
The following services are requested more often:
- The preparation of performance evaluation plans (PEPs)
- The drafting of performance evaluation reports (PERs)
