Managing Medical Devices within a Regulatory Framework

<p>Foreword, Larry Fenningkoh</p> <p>1. Reframing Product Life Cycle for Medical Devices, Beth Fiedler </p> <p>2. Overview of Medical Device Clinical Trials, Beth Fiedler, Michael Ferguson</p> <p>3. Review Regulatory Guidelines by Device Classification Type, Beth Fiedler </p> <p>4. Manufacturing/Distribution, Beth Fiedler </p> <p>5. Overview and Application in Clinical Engineering, Beth Fiedler </p> <p>6. Roles of Biocompatibility, Beth Fiedler </p> <p>7. Risk Management, Beth Fiedler, Abdullah Farid</p> <p>8. Sterility and Reusability, Beth Fiedler </p> <p>9. EU National Differences and Potential Impact on CE Marking, Beth Fiedler </p> <p>10. Understanding the Transitioning Regulatory EU Market, Beth Fiedler </p> <p>11. Evaluating new medical equipment purchases, Beth Fiedler </p> <p>12. Evaluating Reimbursement Strategies in the US, Beth Fiedler , Jeremiah Greathouse</p> <p>13. Healthcare Facility Users Legal Responsibilities and Risks, Marc Sanchez</p> <p>14. Clinical and Biomedical Engineering Evidence Strategy, Beth Fiedler </p> <p>15. Device Failure Tracking and Response to Manufacturing Recalls, Beth Fiedler </p> <p>16. Health Economics and Outcomes Research and Evidence Strategies, Michael Ferguson</p> <p>17. The Future of Health Technology Management, Beth Fiedler </p> <p>18. Challenges of New Technology: Securing Medical Devices and Their Software for HIPPA Compliance, Beth Fiedler </p> <p>19. Managing Smartphone and Tablet Applications, Beth Fiedler </p>