Medical device and medical writing competence for writing of Clinical Evaluation Report
|Coordinator||Sigrid Therapeutics AB - Sigrid Therapeutics|
|Funding from Vinnova||SEK 199 500|
|Project duration||May 2018 - June 2018|
|Venture||Medtech4Health: Competence Enhancement in SME|
Purpose and goal
The purpose of the project was to hire a medical device specialist with competence in medical writing to help structure and write a complete Clinical Evaluation Report (CER) according to MEDDEV 2.7.1 rev 4. The hired Consultant planed, collected and analysed all available data on the product´s safety and performance. The data gathering and analysis resulted in the writing of a first draft of the CER by the Consultant. The CER revealed the information gaps with regards to the product that the Company will now to bridge with data from the planned clinical study.
Expected results and effects
A first draft of the Clinical Evaluation Report has been compiled that details all the collected data on the Company´s product and identifies the gaps which can only be bridged with the planned clinical trial.
Planned approach and implementation
The hired consultant shall plan, collect and analyze relevant data concerning the product´s safety and and performance. This work shall result in the compilation of a "Clinical evaluation report" according to MEDDEV 2.7.1.rev 4. which shall point to the information gaps that the Company needs to bridge in the upcoming clinical trial.