Managing Medical Devices Within a Regulatory Framework – Ebook PDF Instant Delivery – ISBN(s): 9780128041796,9780128041925,012804179X,0128041927
Product details:
- ISBN-13: 978-0128041796
- Author: Beth Ann Fiedler
Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle.
Table contents:
Section 1. Medical Device Development and Regulatory Overview
Chapter 1. Reframing Product Life Cycle for Medical Devices
Chapter 2. Overview of Medical Device Clinical Trials
Chapter 3. Review Regulatory Guidelines by Device Classification Type
Chapter 4. Manufacturing/Distribution Considerations
Section 2. Defining and Meeting Regulatory Challenges in Clinical Engineering
Chapter 5. Defining and Meeting Regulatory Challenges in Clinical Engineering
Chapter 6. Role of Biocompatibility
Chapter 7. Risk Management
Chapter 8. Sterility and Reusability
Section 3. European Markets
Chapter 9. European Union National Differences and Potential Impact on CE Marking
Chapter 10. Understanding the Transitioning Regulatory EU Market
Section 4. Equipment Acquisition, Integration and Maintenance
Chapter 11. Evaluating New Medical Devices Purchases
Chapter 12. Evaluating Reimbursement Strategies in the US
Chapter 13. Healthcare Facility Users’ Legal Responsibilities and Risks
Section 5. Data Management, Patient Safety, and Efficacy
Chapter 14. Clinical and Biomedical Engineering Evidence Strategy
Chapter 15. Device Failure Tracking and Response to Manufacturing Recalls
Chapter 16. Health Economics Outcomes Research and Evidence Strategies
Section 6. Future of Healthcare
Chapter 17. The Future of Health Technology Management
Chapter 18. Challenges of New Technology: Securing Medical Devices and Their Software for HIPPA Compliance
Chapter 19. Managing Smartphone and Tablet Applications
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