Dr. Bernhard Schwartz BSc MSc, is a researcher at the University of Vienna and at the University for Applied Sciences for Health Professions Upper Austria as well as a co-founder of Competence Center for Medical Devices GmbH (CCMD). As scientific member and biometrician at an institutional ethics board and laureate of an Austrian State Price for science (Award of Excellence), he - in partnership with the other CCMD members - supports customers in the pharmacological and medical technology industry in planning, execution and statistical analysis of clinical trials. In addition, Bernhard regularly conducts systematic reviews, clinical evaluations and mini health technology assessments (mini HTAs). Based on his former experience in the field of toxicology (Seibersdorf Laboratories) and medical devices (University for Applied Sciences Upper Austria), he has a perfect background for solving clinical and technical problems.
"The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR).
This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical...
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