Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation
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- Taschenbuch ausgewählt
- eBook
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Sprache:Englisch
Fr. 81.90
inkl. gesetzl. MwSt.,
Beschreibung
Produktdetails
Einband
Taschenbuch
Erscheinungsdatum
04.06.2020
Abbildungen
46 Farbabb.
Verlag
BoD – Books on DemandSeitenzahl
280
Maße (L/B/H)
22/17/1.8 cm
Gewicht
493 g
Auflage
1
Sprache
Englisch
ISBN
978-3-7519-3766-5
"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
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