Download Book Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation, 1st Edition - E-Book - PDF
EPUB + Converted PDF by Wolfgang Ecker, Gerold Labek, Tarquin Mittermayr
Information
Format: EPUB + Converted PDF Language: English Pages: 280 pages Edition: 1 Publisher: BoD - Books on Demand (June 4, 2020) Publication Date of the Electronic Edition: 2020
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ISBN: 9783751937665, 9783751937665, 9783751929288, 3751929282
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Description
"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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