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
EU-MDR Technical File Authoring
EU-MDR Technical File Authoring Introduction Medical Technology Client Our client is a leader in high-quality, surgeon-designed, innovative ophthalmic products located in the US with operations globally. These range from Class I through to Class III devices. Apotech Consultants Our consultants take a risk-based approach to improve quality and compliance, and implement practical solutions for your…
A genetic testing kit manufacturer Journey to UKCA Marking with Apotech
Introduction The client In response to the UK’s new post-Brexit regulatory requirements, our client, an innovative genetic testing kit manufacturer, collaborated with Apotech to achieve UKCA marking. This strategic move was aimed at maintaining their market presence in the UK, ensuring uninterrupted access for their cutting-edge products. Types Scope of work Apotech provided end-to-end support…
510(k) Submission
510(k) Submission Introduction Radiographic Dental Imagery Device – Class IIb Our client are a leading manufacturer of radiographic dental imaging systems, based in Europe. Following European success, our client set their sights on the US market. Standards & Tools FDA 21 CFR Part 820 GDPR Word Excel, Powerpoint Scope of work Review of documentation for…