(Ebook PDF) Managing Medical Devices Within a Regulatory Framework 1st Edition by Beth Ann Fiedler 0128041927 9780128041925 full chapters

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Product details:

ISBN-10 :  0128041927 

ISBN-13 :  9780128041925

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.

This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements.

 

Managing Medical Devices Within a Regulatory Framework 1st Table of contents:

Section 1. Medical Device Development and Regulatory Overview
Chapter 1. Reframing Product Life Cycle for Medical Devices
1.1. Introduction
1.2. FDA Total Product Life Cycle
1.3. European Commission Product Life Cycle
1.4. Summary
Definitions
Chapter 2. Overview of Medical Device Clinical Trials
2.1. Introduction
2.2. Medical Device Submissions Overview
2.3. Medical Device Clinical Trials
2.4. Regulatory Profile of the US Medical Device by Classification Type
2.5. Regulatory Profile of the EU Medical Device by Classification Type
2.6. Summary
Definitions
Chapter 3. Review Regulatory Guidelines by Device Classification Type
3.1. Introduction
3.2. Basic Overview of the Premarket Notification 510(k)
3.3. Premarket Approval Application Regulatory Path
3.4. Medical Device Class I
3.5. Medical Device Class II
3.6. Medical Device Class III
3.7. Summary
Definitions
Chapter 4. Manufacturing/Distribution Considerations
4.1. Introduction
4.2. US Preclinical Stage
4.3. US Postmarket Stage
4.4. European Union CE Marking: Premarketing Stage
4.5. EU Postmarket Stage
4.6. Summary
Definitions
Section 2. Defining and Meeting Regulatory Challenges in Clinical Engineering
Chapter 5. Defining and Meeting Regulatory Challenges in Clinical Engineering
5.1. Introduction
5.2. Biocompatibility
5.3. Risk Management
5.4. Sterility and Reusability
5.5. Summary
Definitions
Chapter 6. Role of Biocompatibility
6.1. Introduction
6.2. Biocompatibility
6.3. US Major Biocompatibility Guidance
6.4. Discussion and Recommendations
6.5. Summary
Definitions
Chapter 7. Risk Management
7.1. Introduction
7.2. The Upside of Interdisciplinary Collaborative Partnerships
7.3. Managing Risk in Healthcare Technology
7.4. Health Information Technology Management in Action
7.5. Summary
Definitions
Chapter 8. Sterility and Reusability
8.1. Introduction
8.2. Sterilization Guidance and Legislation for Medical Device Developers
8.3. Sterilization Guidance and Legislation for Manufacturing
8.4. Sterilization Guidance and Legislation for Hospitals
8.5. Discussion and Summary
Definitions
Section 3. European Markets
Chapter 9. European Union National Differences and Potential Impact on CE Marking
9.1. Introduction
9.2. Germany
9.3. United Kingdom
9.4. France
9.5. Italy
9.6. Discussion and Conclusions
Definitions
Chapter 10. Understanding the Transitioning Regulatory EU Market
10.1. Introduction
10.2. Clinical Trial Regulation
10.3. Summary
Section 4. Equipment Acquisition, Integration and Maintenance
Chapter 11. Evaluating New Medical Devices Purchases
11.1. Introduction
11.2. Medical Device Regulation General Overview
11.3. Evidence-Based Medicine
11.4. End User Purchasing Stakeholders
11.5. Clinical Evidence Strategies
11.6. Comparative Technologies
11.7. Medical Device Integration into Existing Workflows
11.8. Summary
Definitions
Chapter 12. Evaluating Reimbursement Strategies in the US
12.1. Introduction
12.2. Business of Medical Technology
12.3. Medical Device Identification and Regulatory Overview
12.4. Three Types of User Payment Methods
12.5. Discussion
12.6. Summary
Definitions
Chapter 13. Healthcare Facility Users’ Legal Responsibilities and Risks
13.1. Introduction
13.2. Premarket Approval in the US
13.3. Postmarket Surveillance: Good Manufacturing Practices
13.4. Device User Facilities: Postmarketing Regulatory Obligations
13.5. Special Regulatory Application for Device User Facilities
13.6. Comparison and Discussion of Obligatory Regulation in the US and EU
13.7. Summary
Definitions
Section 5. Data Management, Patient Safety, and Efficacy
Chapter 14. Clinical and Biomedical Engineering Evidence Strategy
14.1. Introduction
14.2. Important Overview for Medical Device Manufacturers: Complaints and Risk
14.3. Health Technology Basics
14.4. Clinical Development of Medical Devices
14.5. Discussion
14.6. Summary
Definitions
Chapter 15. Device Failure Tracking and Response to Manufacturing Recalls
15.1. Introduction
15.2. Regulation Definitions and Overview
15.3. Summary
Definitions
Chapter 16. Health Economics Outcomes Research and Evidence Strategies
16.1. Introduction
16.2. Health Economics for Medical Devices
16.3. Value Assessment Process
16.4. Clinical and Outcomes Data
16.5. Types of Economic Evaluation
16.6. Other Health Economics Proxy Measures
16.7. Dissemination Strategies and Tools for Health Economic Evidence
16.8. Conclusion
Definitions
Section 6. Future of Healthcare
Chapter 17. The Future of Health Technology Management
17.1. Introduction
17.2. Emerging Technologies: Seeing the Future Now
17.3. Planning Medical Device Development
17.4. Summary
Definitions
Chapter 18. Challenges of New Technology: Securing Medical Devices and Their Software for HIPPA Compliance
18.1. Introduction
18.2. Regulation
18.3. Challenges of Securing New Technology
18.4. Alert Mechanisms and Agency Resources
18.5. Compliance Solutions
18.6. Summary
Definitions
Acronyms
Chapter 19. Managing Smartphone and Tablet Applications
19.1. Introduction
19.2. Regulations
19.3. Managing Digital Technology: The Device is Right
19.4. Summary

 

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