Clinical Evaluation Report

Ensure Regulatory Compliance & Market Success

Crafting a Clinical Evaluation Report (CER) is a critical and challenging task for medical device manufacturers. With extensive experience in the medical device industry, the Cliniture team understands the importance of the CER for securing regulatory approval for all of your indications and claims. Harnessing our expertise and industry know-how, we maximize your clinical data and the published state-of-the-art data, transforming them into high-quality documents that fully comply with the Regulation (EU) 2017/745 (MDR).

The Challenge

Clinical Evaluation Report

Clinical Evaluation involves systematically assessing a medical device's safety and performance to ensure compliance with regulatory requirements. This in-depth process includes demonstrating conformity with safety standards, suitability for its intended purpose, and maintaining an acceptable benefit-risk ratio. Each device must undergo periodic evaluation, summarized in a Clinical Evaluation Report (CER) based on its risk class.

However, conducting a Clinical Evaluation is no small undertaking. It requires a combination of skills and regulatory know-how, expertise in writing MDR-compliant reports, navigating tight deadlines, addressing previous non-conformities, and adapting to evolving guidelines that are continuously published.

This is where Cliniture can help.

How Cliniture Helps

Our dedicated experts can assist you with all aspects of the Clinical Evaluation, including literature searches and data review and analysis. We work closely with your team to prepare or update Clinical Evaluation Plans (CEPs) and CERs to the highest standards that meet MDR requirements.

CEP scoping & writing
Gap analysis
Benefit-risk analysis
Demonstration of equivalence and/or similarity
Literature searches
Comprehensive and systematic state-of-the-art review
Post-submission Notified Body support
Working with tight deadlines and re-submissions

"I had the pleasure of working closely with Cliniture on multiple challenging projects. Lihi’s exceptional problem-solving skills and strong attention to detail were instrumental in the success.

I highly recommend Lihi, Victoria, and the Cliniture team members for their exceptional attention to customer needs, dedication, professionalism, and ability to deliver results. Their capacity to understand and anticipate customer requirements was key to delivering outstanding service."