As part of conducting a thorough literature review and clinical evaluation report for EU MDR, it is important to establish a framework that accounts for the generally accepted current knowledge, or the state of the art (SOTA). There is no one size fits all recipe, however. Identifying relevant literature for state of the art is a relatively complex process, and retrieving adequate documentation may be challenging.
How can you develop a methodologically sound framework to include sufficient content to demonstrate state of the art and support claims of device equivalence?
In this webinar roundtable, DistillerSR customers, Shelley Jambresic from Geistlich Pharma and Monique Liston from NuVasive are joined by Dr. Julien Senac from TÜV SÜD and moderated by Dr. Bassil Akra from AKRA Team GmbH. They will reflect on challenges and opportunities for medical device companies establishing state of the art (SOTA) for clinical evaluation reports (CER) as part of their compliance path.