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Könyv A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports Joy Frestedt

A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports

Szerző: Joy Frestedt
Nyelv: Angol
Kötés: Puha kötésű
Kiadó: Elsevier Inc
Elérhetőség: Beszállítói készleten
Küldés 14-21 napon belül
63 945 Ft
A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports gui...

Információk a könyvről

Szerző
Joy Frestedt
Nyelv
Angol
Kötés
Könyv - Puha kötésű
Kiadva
2024
oldal
450
EAN
9780443220630
Enbook ID
43435550
Kiadó
Elsevier Inc
Súly
1246
Méretek
191 x 235

Teljes leírás

A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. Identifies and explains data analysis for clinical evaluation of medical devices Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing

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