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Regulatory affairs

Clinical evaluations (MD), PMCF and SSCP

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Clinical evaluations (MD), PMCF and SSCP

Ensuring the compliance of your medical device with the Medical Device Regulation (MDR, 2017/745) is a crucial endeavour, and clinical evaluation stands as a cornerstone activity in this process. We understand the importance of assembling a skilled team for this task, and that’s where we come in to assist you. This team may include consultants with specific professional skills.

We are ready to support you in conducting clinical evaluations, helping you prepare comprehensive Clinical Evaluation Plans (CEPs) and Reports (CERs). We deploy resources with specific expertise to ensure a thorough approach: scientific and clinical experts for data retrieval, extraction, and interpretation, alongside regulatory specialists who ensure the accurate framing of your findings within the context of regulatory compliance.

We offer assistance in independent verification of previously conducted clinical evaluations, as well as crafting scientific and clinical rationale tailored for regulatory purposes. Whether you require full-service support or assistance with specific tasks such as literature searches or data extraction, we’ve got you covered. Plus, we can help you identify clinical experts with the precise expertise needed to contribute to the drafting or revision of CERs/PERs. Clariscience can also help in identifying clinical experts with the most appropriate expertise to contribute to the drafting and/or revision of CERs/PERs.

Our support extends beyond initial evaluations. We’re here to assist you in all Post-Market Clinical Follow-up (PMCF) activities and the drafting of Summaries of Safety and Clinical Performance (SSCPs), ensuring comprehensive coverage of your clinical evaluation needs.

Among our most requested services are:

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Incontra Clariscience al 63° Simposio AFI dal 5 al 7 giugno

Preoccupazione da MDR? Clariscience è la soluzione per i tuoi DM a base di sostanze

Vuoi saperne di più su come possiamo supportarti nell’adeguamento all’MDR per i tuoi dispositivi medici a base di sostanze? Prenota un appuntamento, in occasione del 63° Simposio AFI, potrai incontrare il nostro team.


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