Our team is led by former notified body 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.
ECLEVAR MEDTECH is uniquely positioned to help you create a strategy for presenting comprehensive clinical evidence and analysis. We know what notified bodies are expecting, and we will prepare your team and documentation accordingly.
Get support from ECLEVAR to solve your non-conformity
Our team brings decades of combined experience in clinical evaluation, regulatory strategy, and notified body operations. We understand the complexities of MDR compliance and are committed to ensuring your documentation meets the highest standards.
Former notified body leadership with deep knowledge of MDCG guidance and clinical evaluation requirements under MDR.
Comprehensive support in developing clinical evidence strategies that align with notified body expectations.
Proven track record of preparing CERs that successfully navigate notified body review processes.
Comprehensive CER support tailored to your needs
Add capacity to your team for support with everything from clinical regulatory strategies to development of CERs.
Get comprehensive clinical regulatory support for entire product lines, including support for CEPs, CERs, and PMCF plans, as well as integration with risk management and other technical documentation.
Under EU MDR and in the UK - Strategic support for establishing claim equivalence under current regulations.
We support you to establish PMCF Report - Comprehensive post-market clinical follow-up documentation.
FSP continue to grow in popularity as sponsors look for innovative outsourcing strategies that enable them to gain efficiencies and accelerate the development of their pipelines. Part of our team can be outsourced into your team and into your location to better understand your business.
Leave it to our team to use our systemized approach to keep your clinical evaluation documentation updated and compliant.
We support you to establish SSCP - Summary of Safety and Clinical Performance documentation.
We support you to establish PMCF Plan - Strategic planning for post-market clinical follow-up activities.
Learn from our experts how to structure your Clinical Evaluation Report to meet notified body expectations and avoid common rejection points.
Watch it now and stay ahead!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. Learn how to structure your documentation for notified body success.
Clinical evaluation report (CER) is a document that describes the device under evaluation, the clinical claims, and the State of the Art of the device group. The documents summarize the clinical data that prove the clinical efficacy and safety of the device under evaluation. The CER use scientifically and systematic sound methods for the assessment and analysis of clinical data to verify the benefice and risk of the medical device when used as intended by the manufacturer.
Learn more about CERA non-quantified or defined clinical claims and clinical benefits. Sometimes, the route of equivalence is misused.
Principal medical writers at ECLEVAR are more than 5 years' experience to 14 years of experience in medical writing.
ECLEVAR MEDTECH has medical surgeons in the board who works half time in the hospital and part time at ECLEVAR to support in defining the key words, the alternative therapeutics and review the state of the Art.
Yes, recent CERs have received positive feedback from notified body for MDR recertification.
Let our experts guide you through the clinical evaluation process and ensure notified body compliance.
