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
Prosthesis manufacturer
Prosthesis manufacturer Introduction As part of their international development strategy, our client wanted to get MDSAP certified with a focus on Canada, Australia and Brazil. They were MDSAP certified within 7 months. Types MDSAP Audit Preparation, Quality Management System Review Scope of work Selecting the certification body (quotes, Q&A) Review of their quality management system…
Quarterly Internal Audits
Quarterly Internal Audits Introduction Quarterly Internal Audits Our client is a start-up medical device manufacturer of a body cooling device, for those with heat stroke. They are based in the UK and are undergoing ISO 13485 certification. Standards & Tools 21 CFR ISO 13485 MDSAP MDR Scope of work Key numbers Excited to work together…
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive cardiac devices, based in Germany and selling to 85 countries worldwide. Apotech consultants Our consultants implemented a risk-based approach to improve quality and compliance, and implement practical solutions for the organisation. Standards &…
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