Clinical Evaluation Docs
CEP and CER are structured documents that comprehensively summarize, review, and analyze clinical data pertaining to a medical device, assessing its safety and performance throughout its intended lifecycle. Medical device manufacturers are required to prepare CEPs and CERs to provide evidence of the device's clinical safety and efficacy, ensuring that it meets stringent regulatory standards and provides a foundation for regulatory approvals and market access, thus safeguarding the well-being of patients and end-users.
More efficiency through experience
Learn why IASON consulting is qualified to assist in writing CERs and CEPs.
Proficiency
Writing CEPs and CERs is our daily business. The wealth of experience generated each day continuously improves our results.
Experience
Looking back to more than 300 CERs under MDR 2017/745, across all device classes and types, we deliver documents you can rely on with high confidence.
Reliability
For 20 years, we have been a stable anchor to our clients, ensuring consistent support in science and regulatory.
Guiding you through every move
We are committed to a transparent and guided document delivery process.
Gap analysis
A gap analysis for a clinical evaluation under MDR 2017/745 involves assessing the disparities between the current state of clinical data and the requirements outlined in MDR 2017/745. This process identifies areas where the clinical evaluation falls short in terms of data completeness, quality, and adherence to regulatory standards. The aim is to pinpoint shortcomings, determine necessary actions, and bridge the gaps to ensure that the clinical evaluation aligns with MDR 2017/745 criteria.
Identify inconsistencies
Prevent deficiencies
Reduce review cycles
Device classification
Determining the right risk classification for medical devices under MDR 2017/745, in light of MDCG 2021-24 and MDCG 2020-5, is challenging for manufacturers. The intricate criteria, combined with overlapping guidelines, create ambiguities, risking misclassification, regulatory delays, and increased costs.
We can help with device classification.
Frequently asked questions
