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Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PER...

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Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)

A Practical Guide for the European Union and Other Countries

Joy Frestedt

Academic Press
Publication date : 2024-09-19

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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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About the book

Author

Joy Frestedt

Imprint

Academic Press

Collection

n.c

Publication date

2024-09-19

Pages

450 pages

Print ISBN

9780443220630

Language

English

Ebook informations

EAN PDF

9780443220647

Price

£127.65

Copy count 45

Print count 45

File size 8202 Ko

Informations accessibility

EAN EPUB DRM-FREE

9780443220647

Price

£127.65

Informations accessibility

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About author(s)

Joy Frestedt

Joy Frestedt Is the President and CEO for Frestedt Incorporated, a consulting group of over 70 experts providing services in broad CRQE areas of clinical trial development and execution, as well as US and international regulatory compliance, management of corporate quality systems, and biomedical engineering. She has managed clinical research, regulatory affairs, and quality systems for more than 40 years and has published more than 100 manuscripts, as well as book chapters. With a PhD in Pathobiology from the University of Minnesota Medical School, her experience includes designing, conducting and overseeing clinical trials as well as negotiating regulatory submissions and developing quality systems for companies like the University of Minnesota, Orphan Medical, Astra Zeneca Pharmaceuticals, Johnson and Johnson, Medtronic, and Mayo Clinical Trial Services.

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