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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). 

Cliniture Advantages

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Record of MDR
Audit Success

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WORLDWIDE

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Experience with various

Notified Bodies  

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Subject Matter Experts, Spanning Complex Fields 

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Experience with High- and Low-risk Medical Devices

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Commitment to

Meeting Deadlines

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Dedicated,

Professional & Creative

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.

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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

“We engaged Cliniture's services to revise clinical evaluation documents and develop PMCF and Clinical Development plans for MDR certification. Lihi and her team were highly motivated and dedicated, and were also very proffesional. They demonstrated an open-minded attitude, and excellent communication skills. Importantly, they adhered to the committed due date, ensuring a timely and efficient process.” 
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Malki Epel, VP QA & RA, Taryag Medical

Our Resources

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