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
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.
