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The Medical Device Industry

The Medical Device Industry PDF
Author: Norman F. Estrin
Publisher: CRC Press
ISBN: 9780824782689
Size: 52.74 MB
Format: PDF
Category : Medical
Languages : en
Pages : 976
View: 1184

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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

Proactive Supplier Management In The Medical Device Industry

Proactive Supplier Management in the Medical Device Industry PDF
Author: James B. Shore
Publisher: Quality Press
ISBN: 0873899318
Size: 72.26 MB
Format: PDF, ePub, Mobi
Category : Business & Economics
Languages : en
Pages : 144
View: 7124

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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.

Design Controls For The Medical Device Industry Third Edition

Design Controls for the Medical Device Industry  Third Edition PDF
Author: Marie B. Teixeira
Publisher: CRC Press
ISBN: 1351261460
Size: 31.84 MB
Format: PDF, ePub, Docs
Category : Medical
Languages : en
Pages : 248
View: 2584

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This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements

Design Controls For The Medical Device Industry

Design Controls for the Medical Device Industry PDF
Author: Marie B. Teixeira
Publisher: CRC Press
ISBN: 9780815365525
Size: 68.63 MB
Format: PDF, Mobi
Category : Medical instruments and apparatus
Languages : en
Pages : 250
View: 2601

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"A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc."

The Medical Device Industry

The Medical Device Industry PDF
Author: John Burton
Publisher: Cambridge Scholars Publishing
ISBN: 1443808393
Size: 53.95 MB
Format: PDF, Mobi
Category : Law
Languages : en
Pages : 200
View: 5908

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The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector. The increase in the complexity of medical device software has introduced new challenges with respect to making medical devices and their associated software safe. Risk management has emerged as key in addressing these challenges. Existing literature on risk management for medical devices has been slow to adequately account for the complex nature of software in modern medical devices. Conversely, excellent progress has been made in the broader Software Engineering community with the production of holistic software risk based models such as the Capability Maturity Model Integration (CMMI®) and SPICE™. However, these models do not account for medical device specific requirements. This book examines the possibility of a unified approach whilst investigating the relevance of the CMMI® SPI model to the medical device regulatory requirements.

Medical Device Technologies

Medical Device Technologies PDF
Author: Gail D. Baura
Publisher: Academic Press
ISBN: 012374976X
Size: 28.11 MB
Format: PDF, ePub, Docs
Category : Science
Languages : en
Pages : 512
View: 3301

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The goal of this textbook is to provide undergraduate engineering students with an introduction to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining 8 chapters are medical device laboratory experiment chapters. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach enables students to quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). Key Features: The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts

Powerful Medical Device Sales Guidebook

Powerful Medical Device Sales Guidebook PDF
Author: Susan Postnikoff
Publisher: UniversityOfHealthCare
ISBN: 1594912645
Size: 75.17 MB
Format: PDF
Category : Medical
Languages : en
Pages : 126
View: 5887

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Powerful Medical Device Sales is a comprehensive guide for the medical device and pharmaceutical sales representative on sales skills to use with doctors and hospitals while observing correct procedures and building trust. It takes the attitude that consultative selling and considerate behavior create the most productive client relationships. It covers the structure of a hospital, medical staff, the hospital pharmacy, the hospital-based pharmacist, the nursing service, policies and procedures for hospital vendors, HIPAA essentials for the sales rep, sexual harassment, FDA regulations, operating room protocols, infectious diseases, Advamed code of ethics, sales professionalism and building trust, customer management, and powerful sales communication. The guide results from the collaboration of an exceptional sales representative, a doctor, a nurse/MBA/marketing executive, and a media expert. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version.

Design Controls For The Medical Device Industry Second Edition

Design Controls for the Medical Device Industry  Second Edition PDF
Author: Marie B. Teixeira
Publisher: CRC Press
ISBN: 1466503548
Size: 34.53 MB
Format: PDF, Mobi
Category : Medical
Languages : en
Pages : 205
View: 6864

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The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.

Medical Device Reliability And Associated Areas

Medical Device Reliability and Associated Areas PDF
Author: B.S. Dhillon
Publisher: CRC Press
ISBN: 1420042238
Size: 62.67 MB
Format: PDF, Docs
Category : Technology & Engineering
Languages : en
Pages : 264
View: 5130

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Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing, and design communities have up-to-date information on current developments, tools, and techniques. Medical Device Reliability and Associated Areas fills this need with broad yet detailed coverage of the field. It addresses a variety of topics related - directly and indirectly - to reliability, including human error in health care systems and software quality assurance. With emphasis on concepts rather than mathematical rigor, a multitude of examples, exercises, tables, and references, this is one resource that everyone connected to the medical device industry must have.

Clinical Evaluation Of Medical Devices

Clinical Evaluation of Medical Devices PDF
Author: Karen M. Becker
Publisher: Springer Science & Business Media
ISBN: 1597450049
Size: 29.39 MB
Format: PDF, Docs
Category : Technology & Engineering
Languages : en
Pages : 360
View: 847

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The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.

Medical Device Approval And Certification System Of East Asia

Medical Device Approval and Certification System Of East Asia PDF
Author: Gyu Ha Ryu
Publisher: DIYPIA
ISBN:
Size: 11.68 MB
Format: PDF
Category : Medical
Languages : en
Pages : 200
View: 7187

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In recent years, even though a medical device industry has been grown rapidly as a next generation global industry, most of markets are dominated by some of major countries. A medical device is distinct from general goods; it requires not only ordinary medical engineering R&D knowledge, but also it involves with each phases of specific market knowledge, experience, and expertise from development to commercialization according to complicated regulatory affairs. Moreover, since the purpose of manufactured medical device is usually not only for domestic market but for overseas expansion, expertise of global medical device industry knowledge are needed, such as each country’s medical device law, data of medical device usage and etc… The book provides comprehensive, yet practical knowledge of product planning, research, development, manufacturing, certification and approval, and distribution of medical device in order to enable readers to conduction of business easily through general R&D education as well as essential subject, medical device approval and certification system. The main purpose of book is to foster practical medical device experts through understanding of medical device approval and certification system of East Asia including Korea, Japan, and China. Since the author has had an experienced working in Ministry of Food and Drug Safety (MFDS), especially in medical device certification department as well as an educator in Universities for a long time, the author contains practical-knowledge-oriented information such as problems and corresponding strategies of each country in an aspect of regulatory affairs based on 『global certification and approval for medical device』, which are distinct from a regular textbook: engineering-education-oriented information for medical device manufacturing. This book describes information of regulatory affairs easily for various class of readers: from a undergraduate and graduate student who are interested in medical device industry to personnel who are performing medical device regulation related work. The contained information is based on public announced material from each country’s regulatory authority. However, the contained information may change in the future due to characteristics of regulatory affairs. Therefore, the author will continuously publish revised edition and respectfully accept requests for revision and improvement. 2016. December Gyu Ha Ryu, ph.D

Korea Medical Devices Directory 2016 2017

Korea Medical Devices Directory 2016 2017 PDF
Author:
Publisher:
ISBN:
Size: 56.74 MB
Format: PDF, ePub, Mobi
Category :
Languages : ko
Pages : 210
View: 6346

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Current State of the Medical Devices Industry Competitiveness of Korean Medical Device Industry Current Status of KMDICA Emergency Equipment Building Technology & Services Diagnostics Equipment Disinfection & Disposal Systems Laboratory & Clinical Equipment Radioligy Medical Imange Equipment Physiotherapy Apparatus ICU Equipment ENT Apparatus Central Supply Equipment & Hospital Facilities Rehabilitation & Orthopedic Equipment Dental Apparatus Ophthalmic Apparatus Medical Image Processing Unit Apparatus For Therapy Medical Consumable Other

The Medical Device Engineers Handbook

The Medical Device Engineers Handbook PDF
Author: Emmet Tobin
Publisher:
ISBN: 9781534783195
Size: 33.23 MB
Format: PDF, ePub
Category :
Languages : en
Pages : 262
View: 7136

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This book aims to create a new standard resource for engineers working in the medical device industry. The objective was to produce an all-in-one reference-style book serving the needs of engineers at different levels in their career journey. It is based on over a decade of experience working within the industry. It draws not only on this experience but on best practices and widely accepted conventions. These practices and conventions are typically shaped by the demands of regulatory bodies and international organisations. Chapters include: Design Controls Validation Planning Risk Management Facilities and Utilities Validation Equipment and Software Validation Process Validation Packaging Validation Test Method Validation 21 CFR Part 11 Electronic Records Measurement Good Manufacturing Practices ISO 13485 Lean Basics Six Sigma Basics Polymer Processing Tools Useful References Page Count (Over 200 pages)