CLINICAL EVALUATION

EU Regulation 2017/745 on medical devices applies from 26 May 2021. The MDR repeals Directives 90/385/EEC and 93/42/EE, respectively on AIMD and medical devices. The scope and emphasis on clinical evaluation is now more comprehensive under the MDR than under the Directives.

OUR services in clinical evaluation

Clinical evaluation ensures that safety and performance of a medical device is based on sufficient clinical evidence throughout its life on the market. Eclevar has extensive experience in the field of clinical evaluation: our team of medical writers is eager to support you.

CER/CEP writing

Our senior medical writers provide comprehensive documentation from scratch, that complies with the requirements of notified bodies.

CLINICAL STRATEGY

Our team advises and assists you in the planning, management and documentation of your clinical evaluation: study design, sample size, sites.

cer/CEP updates

Regular updating of your CER is required, especially following new PMS and PMCF data. We can assist you in this step allowing you to remain in compliance.

LITERATURE REVIEW

We support you with a systematic and methodical approach to literature review to collect, review and report on large sets of published data.

A TEAM WITH PROVEN expertise

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ANALYTICAL MINDSET

Our senior medical writers have extensive experience in the interpretation of research data and statistics.

COMMUNICATION SKILLS

Our teams create effective communication and coordination with the different people involved in the process.

PROACTIVE APPROACH

We anticipate client needs, identify possible improvements and offer input to make the process more efficient.

Want to know more about our clinical evaluation services?

EMAIL US TO DISCUSS HOW WE CAN HELP YOU