After months of work it is finally done!
This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking.
One of the authors is Brigitte Raffeiner, PMSc., who has many years of experience in the handling of clinical studies.
The book can be ordered now at: https://www.bod.de/buchshop/clinical-evaluation-and-investigation-of-medical-devices-under-the-new-eu-regulation-wolfgang-ecker-9783751937665