Clinical evaluation is one of the key activities to prove the compliance of a medical device with the requirements of the Medical Device Regulation (MDR, 2017/745). It is good practice for the Manufacturer to assemble a team of people with different skills for this very purpose. This team may include consultants with specific professional skills.
Clariscience can assist the customer in conducting this activity, contributing to the preparation of the Clinical Evaluation Plan (CEP) and Report (CER), through the deployment of resources with specific transversal skills: scientific/clinical, for the retrieval, extraction and interpretation of clinical data, and regulatory, to ensure the correct framing of what is found in the context of proving device compliance.
Clariscience can also help with the independent verification of clinical evaluations (MD) that have already been conducted, as well as with the elaboration of specific scientific/clinical rationale for regulatory purposes, and with the performance of only some of the tasks related to clinical evaluations (e.g. literature searches alone, data extraction alone). Clariscience can also help in identifying clinical experts with the most appropriate expertise to contribute to the drafting and/or revision of CERs/PERs.
Support in all Post-Market Clinical Follow-up (PMCF) activities and drafting of Summaries of Safety and Clinical Performance (SCCPs) completes the range of services.
The following services are requested more often:
- Preparation of clinical evaluation plans (CEPs)
- Drafting of clinical evaluation reports (CERs)
- Drafting PMCF plans and reports
- Drafting of Summaries of Safety and Clinical Performance (SSCPs)
