Planning, writing and reviewing medical device clinical and performance evaluation reports (CERs/PERs) : a practical guide for the European Union and other countries /
A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices that is in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings toge...
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| Format: | eBook |
| Language: | English |
| Published: |
London :
Academic Press,
[2025]
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| Online Access: | Connect to the full text of this electronic book |
| Summary: | A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices that is 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. |
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| Physical Description: | 1 online resource. |