Clinical Evaluation Plan (CEP)
Clinical Evaluation Plans (CEPs) for medical devices in the EU, UK, and other global markets are critical documents that ensure safety and performance before market entry. CEPs outline a systematic approach to gathering clinical data, assessing performance, and evaluating risk–benefit profiles
EU MDR 2017/746 requires a risk-based approach and comprehensive clinical evidence to support claims.
Trusted by top-tier teams worldwide
Apotech can support with:
- Clinical evaluation summary and route
- Device description, state-of-the-art status and equivalence
- Risk management
- Literature search strategy
- Data analysis and evaluation
Featured case studies
Software as a medical device (SaMD)
Software as a medical device (SaMD) Introduction Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin. Types Regulatory affairs Responsible person FSP Scope of work Our client recently partnered with groups of clinics in the United Kingdom and therefore asked us to act as their UK…
QMS Implementation for Class III Medical Device
QMS Implementation for Class III Medical Device Introduction Streamlining ISO 13485 Certification for a connected medical device. The company is a highly innovative start up, which has developed a best-in-class pacemaker. At the time of engaging with them they were on the road to CE Marking. Apotech Team Worked full time on the project: balanced…
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…
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