Approach data capture with confidence
Implement and oversee your trial with ease
Our team is led by former notified body and competent authority leadership. They have significantly contributed to MDCG guidance documents on clinical evaluation, sufficient clinical evidence, and PMCF. They were also involved in the development of the requirements of MEDDEV 2.7/1 rev 4, which are now reflected in the MDR.
At the end of a clinical trial, there is usually limited knowledge of the medium and long-term safety and performance of the device. The medium- and longer-term safety and performance of a device is estimated on the basis of premarket trial durations, that are generally inadequate to validate extrapolation hypothesis in real life, particularly implant longevity hypotheses.
The aims of collecting RWE data as part of PMCF activities are:
ECLEVAR can help in collecting the clinical data required and provide long-term clinical strategy that support your business in EU, UK and Australia.
Collect scientifically valid and MDR compliant PMCF data using our platform:
Easy GDPR compliance.
Easily comply with GDPR requirements for informed consent and data protection. Our in house data protection officer monitor the compliance for all the studies
Pre-validated and compliant data platform: Our platform is compliant with ISO14155:2020 requirements and GDPR.
Fully documented data traceability. All data inputs automatically include automatic user identification to ensure fully documented traceability from source to sponsor via using State of The Art technology Blockchain
The main objective of any clinical evaluation is to demonstrate the safety and performance of a medical device. This is an essential process that is part of the conformity assessment procedure for obtaining the CE mark.
In the MDR, the scope and emphasis of the clinical evaluation is more important than in the MDD.
Eclevar, a CRO specialized in medical devices, hosts a 45-minute webinar dedicated to the changes in clinical evaluation under the MDR. In this webinar, we will review the requirements for clinical evaluation and the best practices to address these changes effectively.