
The Future of Medical Device Regulation
Innovation and Protection
- English
- PDF
- Available on iOS & Android
The Future of Medical Device Regulation
Innovation and Protection
About this book
Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.
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Information
Table of contents
- Cover
- Half-title page
- Title page
- Copyright page
- Dedication
- Contents
- List of Figures
- List of Tables
- List of Contributors
- Acknowledgments
- Volume Introduction
- Part I AI and Data as Medical Devices
- Part II European Regulation of Medical Devices
- Part III Designing Medical Device Regulations
- Part IV The Impact of Medical Device Regulation on Patients and Markets
- Part V Medical and Legal Oversight of Medical Devices