Clinical Evaluation Report Template: a Free Resource for Medical Device Manufacturers

On-demand clinical evaluation specialists

The CER is often one of the most challenging aspects of the medical device regulatory process, requiring a high level of expertise and considerable investment of time and resources. As the expert economy grows, however, companies can now access highly-qualified specialists who can help them meet all the industry standards needed for approval. The EU MDR regulation, which was previously supposed to be implemented in May 2020, was delayed by a year due to the pandemic and came into effect in May last year. In that one year, a growing number of people left their jobs in search of better opportunities that offered flexibility. As research funding was cut, scientists around the world found themselves looking for alternative sources of income while also offering their expertise on an on-demand basis. Medical device businesses, who had worked traditionally until then, started hiring freelancers for one-off projects. Data from Kolabtree shows that from 2019 to 2021, there was an increase in the demand for clinical evaluation report writers in companies both big and small, and all of these jobs mentioned that the position was ‘work from home’. Ashmita Das, CEO of Kolabtree, says, “Since the pandemic hit, medical device manufacturers have been adapting new and flexible ways of working. At Kolabtree, we are connecting medtech companies to a global pool of medical device experts, who can help with regulatory compliance, product development and medical writing. This helps businesses save costs and time, while accessing the expertise they need to push the boundaries of innovation.” The CER sample has been sourced from Kolabtree consultant Girish Hirpara, a CER expert and regulatory consultant with more than 14 years of experience in the medical device industry. Download the CER sample by filling in the form on this page.