Understanding Medical Devices An Introduction To The Medical Device Industry

Understanding Medical Devices  an Introduction to the Medical Device Industry PDF
Author: Shalinee Naidoo
Publisher: Arcler Press
Category : Technology & Engineering
Languages : en
Pages : 290
View: 3799

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Book Description:
Understanding Medical Devices: An introduction to the medical device industry throws light on the meaning of medical devices and the effects that the global trends have on their usage and demand. It informs about the research that is aimed at improving the medical devices and the various solutions to overcome the barriers in the choosing of medical devices. The book makes the readers understand the various guidelines for medical device donations and throws light on the importance of public health in this sector. Also discussed in the book are the examples of various medical devices, the essential principles of safety and performance, the use of standards by the regulatory bodies, the various phases of medical device development, the responsible entity for the medical devices and the way the medical device industry has globalized.


Public Health Effectiveness Of The Fda 510 K Clearance Process

Public Health Effectiveness of the FDA 510 k  Clearance Process PDF
Author: Institute of Medicine
Publisher: National Academies Press
Category : Medical
Languages : en
Pages : 140
View: 5990

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Book Description:
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.


Design Controls For The Medical Device Industry

Design Controls for the Medical Device Industry PDF
Author: Marie Teixeira
Publisher: CRC Press
Category : Medical
Languages : en
Pages : 254
View: 4156

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Book Description:
This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize


Proactive Supplier Management In The Medical Device Industry

Proactive Supplier Management in the Medical Device Industry PDF
Author: James B. Shore
Publisher: Quality Press
Category : Business & Economics
Languages : en
Pages : 144
View: 5400

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Book Description:
In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business aspect. The intent of this book is to show readers a process of effectively selecting, evaluating, and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, consultants, and contractors in a state of compliance. These processes can be applied to all suppliers, consultants, and contractors. In writing this book, the authors made sure that readers could immediately apply its content. They provide best practices based on a combined 50+ years of quality and engineering experience, having worked with some of the best medical device companies and contract manufacturers in the world. Four icons use throughout the book help readers navigate and understand the content. The FDA and toolbox icons assist in determining whether it’s a requirement or a tool to help achieve compliance. The “Lessons from the Road” icon indicates real-life stories and what the authors have learned throughout their careers. Lastly, the check mark icon is used to highlight key thoughts, what they feel are unique takeaways or deserve a special focus.


The Medical Device Industry

The Medical Device Industry PDF
Author: Norman F. Estrin
Publisher: CRC Press
Category : Medical
Languages : en
Pages : 976
View: 3691

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Book Description:
Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach


Innovation And Invention In Medical Devices

Innovation and Invention in Medical Devices PDF
Author: Institute of Medicine
Publisher: National Academies Press
Category : Medical
Languages : en
Pages : 112
View: 6059

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Book Description:
The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.


The Changing Economics Of Medical Technology

The Changing Economics of Medical Technology PDF
Author: Institute of Medicine
Publisher: National Academies Press
Category : Medical
Languages : en
Pages : 224
View: 7752

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Book Description:
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policies--as well as the involvement of numerous government agencies--affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.


Trends In Development Of Medical Devices

Trends in Development of Medical Devices PDF
Author: Prakash Srinivasan Timiri Shanmugam
Publisher: Academic Press
Category : Technology & Engineering
Languages : en
Pages : 216
View: 3698

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Book Description:
Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities