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Cover: 9783751937665 | Clinical Evaluation and Investigation of Medical Devices under the...
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Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation
Taschenbuch von Wolfgang Ecker (u. a.)
Sprache: Englisch

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Beschreibung
"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 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
"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 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
Über den Autor
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.
Details
Erscheinungsjahr: 2020
Fachbereich: Allgemeine Lexika
Genre: Medizin
Rubrik: Wissenschaften
Medium: Taschenbuch
Inhalt: 280 S.
46 farbige Illustr.
ISBN-13: 9783751937665
ISBN-10: 3751937668
Sprache: Englisch
Ausstattung / Beilage: Paperback
Einband: Kartoniert / Broschiert
Autor: Ecker, Wolfgang
Labek, Gerold
Mittermayr, Tarquin
Raffeiner, Brigitte
Ring, Michael
Schwartz, Bernhard
Hersteller: Books on Demand GmbH
BoD - Books on Demand
Maße: 220 x 170 x 18 mm
Von/Mit: Wolfgang Ecker (u. a.)
Erscheinungsdatum: 04.06.2020
Gewicht: 0,493 kg
Artikel-ID: 118501296
Über den Autor
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.
Details
Erscheinungsjahr: 2020
Fachbereich: Allgemeine Lexika
Genre: Medizin
Rubrik: Wissenschaften
Medium: Taschenbuch
Inhalt: 280 S.
46 farbige Illustr.
ISBN-13: 9783751937665
ISBN-10: 3751937668
Sprache: Englisch
Ausstattung / Beilage: Paperback
Einband: Kartoniert / Broschiert
Autor: Ecker, Wolfgang
Labek, Gerold
Mittermayr, Tarquin
Raffeiner, Brigitte
Ring, Michael
Schwartz, Bernhard
Hersteller: Books on Demand GmbH
BoD - Books on Demand
Maße: 220 x 170 x 18 mm
Von/Mit: Wolfgang Ecker (u. a.)
Erscheinungsdatum: 04.06.2020
Gewicht: 0,493 kg
Artikel-ID: 118501296
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