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Medical device and medical writing competence for writing of Clinical Evaluation Report

Reference number
Coordinator Sigrid Therapeutics AB - Sigrid Therapeutics
Funding from Vinnova SEK 199 500
Project duration May 2018 - June 2018
Status Completed
Venture Medtech4Health: Competence Enhancement in SME
Call Medtech4Health: competence enhancement for smaller companies

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.

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 25 November 2019

Reference number 2018-02084

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