As part of conducting a clinical evaluation, the Clinical Evaluation Plan (CEP) helps to identify both favourable and unfavourable data as well as to critically appraise and analyse current scientific information available on the devices under evaluation as well as related devices in case of newly developed products. IASON consulting provides long-term expertise concerning the creation of mandatory documents for market entry and for devices already available on the market.
Performance and safety risks and concerns to the patient and the user by the device as well as any clinical and / or residual risks, after design risk mitigation strategies have been employed, are addressed in the CEP.
CEPs by IASON consulting are regularly created in compliance with MEDDEV 2.7/1 revision 4 and the MDR 2017/745 becoming legally binding in mid-2020.
The CEP provides information as well as a strategy for the accumulation of pertinent data (and any changes) from applicable published literature, standards and guidance documents including information on the data source(s).
This forms an important step prior to compiling a Clinical Evaluation Report
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