Articles liés à Planning, Writing and Reviewing Medical Device Clinical...

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

Frestedt

 
9780443220630: Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)
Couverture souple
ISBN 10 : 0443220638 ISBN 13 : 9780443220630
Editeur : Academic Press, 2024

Synopsis

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.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

À propos de l'auteur

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.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
Academic Press
Date d'édition
2024
Langue
anglais
ISBN 10 
0443220638
ISBN 13 
9780443220630
Reliure
Broché
Nombre de pages
546
Coordonnées du fabricant
Academic Press
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