Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation
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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.
It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups, spin-offs or other development projects or in counselling services." Dr. Tom Melvin, Co-Chair, Clinical Investigation and Evaluation Working Group
Hon (FH) Prof. Dr. Wolfgang Ecker MD, graduated at the Medical Faculty of the University of Vienna, has accomplished his medical training as GP in various Viennese hospitals. He has served the Austrian Health Ministry and the EU Medical Device Sector for 30 years. He has been member of various expert groups at EU level, i.a. as Chair of the EU Working Group on Clinical Investigation and Evaluation (CIE) and as an EU representative in GHTF Study Group 5 on Clinical Evidence. As a member of the EU Council Working Group on Medical Devices, he has helped shaping the new EU Regulations on Medical Devices and IVDs. He is giving lectures and training seminars on these new Regulations at various Universities of Applied Sciences in Austria and at Health Technology Clusters.
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.
Tarquin Mittermayr BA(Hons) MA, is an Information Specialist at the Austrian Institute for Health Technology Assessment (AIHTA), where he is responsible for the information management including the systematic searching for scientific literature. He studied History, Archive and Museum Studies as well as German, European Studies and Bookbinding. He worked as an assistant librarian at the monastery of St. Florian, as an Information Assistant at Roehampton University and St. George's Hospital Medical School (University of London), and more recently as an archivist at the Konrad Lorenz Institute for Evolution and Cognition Research.
Brigitte Raffeiner PMSc, is CEO of the Competence Center for Medical Devices GmbH (CCMD). Her personal focal points in the company are corporate management, project management, monitoring and data management. She can look back on many years of experience in the handling of clinical studies. Together with her partners, she supports companies in successfully bringing their products to market.
DI (FH) Dr. Michael Ring, is co-founder and one of the managing directors of R'n'B Consulting GmbH and co-founder and consultant at the Competence Center for Medical Devices GmbH (CCMD). Together with his business partners and co-operation partners, he supports companies in the medical technology industry in the compliant implementation of the process of the clinical evaluation, including the conduct of clinical investigations and systematic literature searches.
In addition, Michael worked from 2014 to 2019 as a study coordinator at the newly established Kepler University Hospital in Linz. His responsibilities included the coordination of sponsored studies and academic research.
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.
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