EU Regulation 2017/745 raises the bar for clinical evaluation. Our senior medical writers build, structure and update your CER/CEP with sufficient clinical evidence, throughout your device life on the market.
EU Regulation 2017/745 repeals directives 90/385/EEC (AIMD) and 93/42/EEC (medical devices). The scope and expectations for clinical evaluation are now significantly stronger.
Clinical evaluation ensures your device safety and performance rest on sufficient clinical evidence. Our medical writing team supports you at every step.
Our senior medical writers produce complete documentation from scratch, compliant with Notified Body requirements.
We advise on planning, managing and documenting your clinical evaluation: study plan, sample size, site selection.
Your CER must be updated regularly, notably after new PMS and PMCF data. We keep you compliant.
A systematic, methodical approach to collect, appraise and report large sets of published data.
Deep experience interpreting research data and clinical statistics.
Effective communication and coordination with every stakeholder in the process.
We anticipate your needs, spot improvements and propose ways to make the process more efficient.
Europe first CRO for EU MDR regulatory affairs, PMCF clinical investigations and clinical data management, with expertise in cardiovascular, orthopaedic, dental and neurology devices.
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