Expertise in Clinical Evaluation Report Writing
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.
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
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.
