Clinical Evaluation Report (CER)
The EU MDR 2017/746 and UK medical device regulations require manufacturers to maintain an up-to-date Clinical Evaluation Report (CER) as part of their technical documentation to obtain CE or UKCA marks.
A CER systematically assesses clinical data to demonstrate safety and performance. It supports regulatory compliance and ensures the medical device conforms to essential requirements.
Trusted by top-tier teams worldwide
Apotech can support with:
- Clinical scope, context, and state-of-the-art assessment
- Device description and development history
- Risk management alignment
- Clinical evaluation methodology
- Literature search execution
- Analysis of safety and performance data
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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