Ass. Prof. Dr Gerold Labek MD, graduated at the medical faculty of Vienna University. He has accomplished training for General Practitioner and senior consultant for orthopedic surgery at AKH Linz (now Kepler University Clinic Linz). He conducted research focused on the topics of registries/real world evidence and quality of published research for almost 20 years and received habilitation at Innsbruck Medical University on research methodology.
He was been working for the Notified Body TÜV SÜD as Di-rector for Clinical Market Surveillance and is active now as clinical expert for several Notified Bodies.
"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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