Medical Device Quality Assurance and Regulatory Compliance
Title | Medical Device Quality Assurance and Regulatory Compliance PDF eBook |
Author | Richard C. Fries |
Publisher | CRC Press |
Total Pages | 496 |
Release | 1998-08-11 |
Genre | Medical |
ISBN | 148227003X |
"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."
Medical Technology
Title | Medical Technology PDF eBook |
Author | United States. General Accounting Office |
Publisher | |
Total Pages | 104 |
Release | 1992 |
Genre | Medical instruments and apparatus |
ISBN |
Medical Device Quality Assurance and Regulatory Compliance
Title | Medical Device Quality Assurance and Regulatory Compliance PDF eBook |
Author | Richard C. Fries |
Publisher | CRC Press |
Total Pages | 504 |
Release | 1998-08-11 |
Genre | Medical |
ISBN | 9780824701772 |
"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."
Medical Device Quality Management Systems
Title | Medical Device Quality Management Systems PDF eBook |
Author | Susanne Manz |
Publisher | Academic Press |
Total Pages | 294 |
Release | 2018-09-27 |
Genre | Science |
ISBN | 0128142227 |
Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans
Medical Device Regulatory Practices
Title | Medical Device Regulatory Practices PDF eBook |
Author | Val Theisz |
Publisher | CRC Press |
Total Pages | 578 |
Release | 2015-08-03 |
Genre | Medical |
ISBN | 9814669113 |
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
To Investigate and Develop a "Quality Helix" Quality Assurance Program with an Emphasis on GMP and FDA Regulatory Compliance for Quality Manufacturing of Medical Devices
Title | To Investigate and Develop a "Quality Helix" Quality Assurance Program with an Emphasis on GMP and FDA Regulatory Compliance for Quality Manufacturing of Medical Devices PDF eBook |
Author | Jason Hon Fu Fok |
Publisher | |
Total Pages | 252 |
Release | 2003 |
Genre | Medical instruments and apparatus |
ISBN |
Pharmaceutical Computer Systems Validation
Title | Pharmaceutical Computer Systems Validation PDF eBook |
Author | Guy Wingate |
Publisher | CRC Press |
Total Pages | 773 |
Release | 2016-04-19 |
Genre | Medical |
ISBN | 1420088955 |
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.