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

A Practical Guide for the European Union and Other Countries
Erscheinungsjahr 2024
ISBN: 978-0-443-22063-0
Verlag: Elsevier Inc

Buch, Englisch, 546 Seiten, Format (B × H): 216 mm x 279 mm, Gewicht: 1251 g

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.

Autoren/Hrsg.

Frestedt, Joy

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien
• Naturwissenschaften Biowissenschaften Angewandte Biologie Bioinformatik
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie
• Mathematik | Informatik EDV | Informatik Angewandte Informatik Bioinformatik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Technische Wissenschaften Sonstige Technologien | Angewandte Technik Medizintechnik, Biomedizintechnik

Inhaltsverzeichnis

1. Preface 2. Introduction 3. Planning Clinical Evaluations of Medical Devices 4. Writing Clinical Evaluation Reports of Medical Devices 5. Identifying clinical data 6. Appraising clinical data 7. Analyzing clinical data 8. Integrating post market surveillance systems 9. Integrating risk management systems 10. Evaluating Risk:Benefit Profiles 11. Incorporating post market clinical follow up studies 12. Writing Summaries of safety and clinical performance 13. Reviewing medical device clinical evaluation reports 14. Understanding CER Regulations outside of Europe 15. Forecasting CER future directions 16. Appendixes 17. Index and Definition of Terms

Über Autor(innen)

Frestedt, Joy
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.