Clinical Evaluation
At Medalps, we support manufacturers in meeting the clinical evidence requirements of Regulation (EU) 2017/745 (MDR) through high-quality, fully compliant clinical evaluations.
Medical writing and Strategy
Our services cover the development and updates of:
​
-
Clinical Evaluation Plans (CEP)
-
Clinical Evaluation Reports (CER)
-
Summary of Safety and Clinical Performance (SSCP)
-
Post-market clinical strategies (PMCF)
​
A key strength of our approach lies in the robust assessment of the state of the art (SOTA). We perform systematic literature reviews to establish medical context, identify therapeutic alternatives, define benchmark devices, and set reference values for safety and performance. Our methodology aligns with MEDDEV 2.7/1 rev. 4 and applicable MDCG guidances.
Whether you need a first-time evaluation or an update for legacy or innovative devices, Medalps ensures that your documentation is both scientifically sound and audit-ready.
We combine regulatory precision with a pragmatic understanding of clinical data challenges. Our work is particularly well-suited to French-speaking manufacturers seeking a culturally aligned partner for their EU regulatory strategy.
Let’s work together to turn complex requirements into confident submissions!