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

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Joy Frestedt (President and CEO, Frestedt Incorporated, St. Louis Park, MN, USA)

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 (President and CEO, Frestedt Incorporated, St. Louis Park, MN, USA)

$272.95

Paperback

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English

Academic Press Inc
24 September 2024

Medical research; Pharmacology; Biology, life sciences; Biotechnology

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.

By: Joy Frestedt (President and CEO Frestedt Incorporated St. Louis Park MN USA)
Imprint: Academic Press Inc
Country of Publication: United States
Dimensions: Height: 276mm, Width: 216mm,
Weight: 1.420kg
ISBN: 9780443220630
ISBN 10: 0443220638
Pages: 576
Publication Date: 24 September 2024
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

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.