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

A Practical Guide for the European Union and Other Countries

Häftad, Engelska, 2024

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

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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 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.

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

Produktinformation

Utgivningsdatum2024-09-24
Mått216 x 276 x undefined mm
Vikt1 420 g
FormatHäftad
SpråkEngelska
Antal sidor576
FörlagElsevier Science
ISBN9780443220630

Tillhör följande kategorier

Biokemisk teknik inom Naturvetenskap och teknik
Biomedicinsk teknik inom Medicin
Biovetenskap inom Naturvetenskap och teknik
Medicinsk utrustning och medicinska tekniker inom Medicin
Farmakologi inom Medicin

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.

1. Preface2. Introduction3. Planning Clinical Evaluations of Medical Devices4. Writing Clinical Evaluation Reports of Medical Devices5. Identifying clinical data6. Appraising clinical data7. Analyzing clinical data8. Integrating post market surveillance systems9. Integrating risk management systems10. Evaluating Risk:Benefit Profiles11. Incorporating post market clinical follow up studies12. Writing Summaries of safety and clinical performance13. Reviewing medical device clinical evaluation reports14. Understanding CER Regulations outside of Europe15. Forecasting CER future directions16. Appendixes17. Index and Definition of Terms