PMCF INVESTIGATIONS

This post-CE marking clinical follow-up consists of collecting real-life clinical data to confirm the medical device performance and safety claims.

This step is complex and the data it generates must be ethically and scientifically valid, reliable and robust, in order to maintain the device on the market.

ENTRUST YOUR PMCF SURVEY TO ECLEVAR

Medical device manufacturers must conduct PMCF surveys to gather additional information on a product already CE marked, unless there is a medico-scientific justification. A PMCF strategy outlined in the Post-Market Surveillance plan is essential to maintain compliance under the MDR.

It is crucial that manufacturers update clinical data available on the medical device to assess the benefit/risk ratio throughout the life of the product.

The Eclevar teams can help you within the PMCF framework, with a global or customized offer, tailored to your challenges.

Research

STUDY DESIGN AND PMCF PLAN

We assist you in the design of your study, from sample size to the development of your plan. We define together the data source and the method of data collection, in accordance with the risk of the device.

IMPLEMENTATION

Our senior medical experts manages the study in order to collect relevant data, ensuring throughout its duration that it is consistent with the PMCF plan.

DATA ANALYSIS

Our team of clinical experts, medical writers and biostatisticians proactively collects the data sets, complaints and questionnaires, and analyzes them to draw conclusions.

REPORTING

We write a PMCF report containing the results of the study and highlighting any emerging or previously unknown risks, thus ensuring the safety and performance of the device throughout its lifetime.

Trust and expertise

The importance of entrusting the responsibilities of managing clinical investigations to knowledgeable and experienced individuals cannot be overstated.

Clinical studies are complex and the data they generate must be ethically and scientifically valid, reliable and robust.