top of page
cliniture logo.png

Expertise in Clinical Evaluation Report Writing

Fill out the form below and we'll get back to you.

Thanks for submitting!

Send us a message

Writing a high-quality, EU MDR-compliant Clinical Evaluation Report can be time-consuming, complicated, and challenging for medical device manufacturers.

Cliniture has the industry knowledge and experience to ensure that all of your regulatory documents can be produced on time and fully comply with MDR requirements.

Cliniture holds a library of CER templates audited and approved by different notifies bodies. We collect and monitor the changing and updating requirements and implement them into our clients’ documents.

Office Time_edited.png

We ensure

Custom clinical evaluation strategy tailored by a team of specialists


Broad search of all the device-related data to support all claims and indications


Comprehensive and systematic state-of-the-art review to include relevant outcome parameters and acceptance criteria

Flawlessly written documents to supports our clients’ good reputation


Integration of safety and performance data into reliable statements

Leverage the cumulative expert knowledge and writing skills from our team of medical writers who have submitted and published hundreds of industry reports from a broad range of therapeutic areas and medical devices of all classifications.

Contact us about how cliniture can work with you
to streamline your medical regulatory needs!


We bring with us

Proven track record of efficient regulatory document production and submission


Industry expertise in a variety of therapeutic areas


Successful communication with notified bodies


Clinical Evaluation Report templates and examples


Excellent service delivery and communication with our clients.

Lihi Levin is the founder and CEO of Cliniture. Lihi holds an MSc. Biology from the Weizmann Institute of Science. She has vast experience of working exclusively in the field of clinical regulation for medical companies.

Cliniture’s team draws on the extensive skills, knowledge and experience of its team of expert medical writers. Our approach is client-focused. We work collaboratively with manufacturers to produce high-quality regulatory documents that are fully compliant with all the regulatory guidelines.

We ensure that all the required documentation is prepared efficiently to ensure timely submission to regulatory agencies. We provide the highest quality customer service by communicating clearly and precisely with our clients to ensure that every important detail of the project is addressed.

Learning Center | clinitrue

Learning Center

Five Important Concepts to Consider when Writing a Clinical Evaluation Report

Writing a Clinical Evaluation Report (CER) is a complex task. Throughout the process, manufacturers frequently discover that there are more documents and further analysis that they should have prepared. These tasks include fully defining the intended purpose of the device, completing thorough systematic reviews of both the scientific literature for ‘state of the art’ research and ‘pivotal’ (device specific) research as well as comprehensive vigilance database searches. To make life easier, we have created a short list of five essential principles to consider before starting a CER.

Five Important Concepts to Consider when Writing a Clinical Evaluation Report

Send  us a message.

Thanks for submitting!

bottom of page