Description
Table of Contents
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
