Why Cliniture?
Creative
We embrace creative thinking to support our clients’ safety and performance claims. Our flexible approach allows us to maximize the potential of existing evidence, utilizing it to its fullest extent.
Specialists
We understand excellence in regulatory compliance matters. With medical-related master’s degrees combined with deep industry know-how, and expertise in Clinical Evaluation and PMS processes, we have you covered.
Service-Orientated
At Cliniture, you are our priority. Our service-oriented commitment ensures rapid responses and high quality solutions, reflecting our unwavering responsibility to achieve success in a timely manner that meets your tight deadlines.
We are Trusted by Leading Companies
As a demonstration of our service quality, we are trusted by great customers as follows.
“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.”
Malki Epel, VP QA & RA, Taryag Medical
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.
