This much-needed guide helps engineers ensure proper maintenance of medical equipment for FDA, CE, and HIPAA compliance and safety, anticipate equipment problems and legal issues, and utilize equipment funding wisely
Foreword, Larry Fenningkoh
1. Reframing Product Life Cycle for Medical Devices, Beth
Fiedler
2. Overview of Medical Device Clinical Trials, Beth Fiedler,
Michael Ferguson
3. Review Regulatory Guidelines by Device Classification Type, Beth
Fiedler
4. Manufacturing/Distribution, Beth Fiedler
5. Overview and Application in Clinical Engineering, Beth
Fiedler
6. Roles of Biocompatibility, Beth Fiedler
7. Risk Management, Beth Fiedler, Abdullah Farid
8. Sterility and Reusability, Beth Fiedler
9. EU National Differences and Potential Impact on CE Marking,
Beth Fiedler
10. Understanding the Transitioning Regulatory EU Market, Beth
Fiedler
11. Evaluating new medical equipment purchases, Beth
Fiedler
12. Evaluating Reimbursement Strategies in the US, Beth
Fiedler , Jeremiah Greathouse
13. Healthcare Facility Users Legal Responsibilities and
Risks, Marc Sanchez
14. Clinical and Biomedical Engineering Evidence Strategy,
Beth Fiedler
15. Device Failure Tracking and Response to Manufacturing
Recalls, Beth Fiedler
16. Health Economics and Outcomes Research and Evidence
Strategies, Michael Ferguson
17. The Future of Health Technology Management, Beth
Fiedler
18. Challenges of New Technology: Securing Medical Devices and
Their Software for HIPPA Compliance, Beth Fiedler
19. Managing Smartphone and Tablet Applications, Beth Fiedler
Beth Ann earned her doctorate in Public Affairs at the University of Central Florida. The author of books on innovative approaches to healthcare quality; Dr. Fiedler has also successfully completed quality-award winning management projects for the private sector and the US military. Her research includes policy analysis focused on healthcare quality and business development presented to U.S. Congressional representatives, medical, technology and business audiences in the US and abroad. She has published in several peer-reviewed journals, was named a Founder’s Fellow by the American Society for Public Administration in 2014 and was featured by the US National Center for Policy Analysis for “Ideas Changing the World on Health Issues.
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