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WELCOME to the Medical Devices Library

Medical Devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care, genetic testing, clinical trials, and experimental clinical investigations. Without medical devices, there is no clinical research or patient care. Without life-adjusting devices, there are no medical procedures or surgery. Without life-saving and life-maintaining devices, there is no improvement in well-being and quality of life. Without innovative medical devices and experimentation, there can be no medical progress or patient safety.
Now please feel free to browse through our Medical Device Library.


ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry

This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. By Itay Abuhav (878 pages)

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Biomaterials, Medical Devices, and Combination Products

Biocompatibility Testing and Safety Assessment.
This book is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices. The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical safety of the materials used in producing medical devices as well as the devices themselves. Each aspect of device safety evaluation is reviewed in terms of the International Organization for Standardization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health, Labour, and Welfare (MHLW) perspectives. By Shayne Cox Gad and Samantha Gad-McDonald (584 pages)

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Usability Testing of Medical Devices

This book covers the nitty-gritty of usability test planning, conducting, and results reporting. Since publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. The book helps ensure a smooth and painless development process-and thus, safe and effective medical devices.By Michael E. Wiklund  P.E. , Jonathan Kendler and Allison Y. Strochlic  (480 pages)

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Medical Device Regulations

Transitioning from MDD 93/42/EEC to MDR 2017/745
The Medical Devices Directive 93/42/EEC was enforced to provide a regulatory environment for all medical devices sold within the European Union however new technologies have challenged the current framework and highlighted gaps. For this reason, there has been a need to update the MDD which led to the release of the Medical Device Regulation EU MDR 2017/745.
By Shalinee Naidoo (277 pages)
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Medical Device Regulations: Transitioning from MDD 93/42/EEC to MDR 2017/745 book
Medical Device Safety book
Medical Device Safety

The Regulation of Medical Devices for Public Health and Safety
 examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. By G.R Higson
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The Medical Device R&D Handbook

Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development.This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.
By Theodore R. Kucklick ( 510 pages)

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International Labelling Requirements for Medical Devices, Medical Equipment and Diagnostic Products

This second edition provides the practical, hands-on labelling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labelling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide by Charles Sidebottom (Paperback 616 pages)
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International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products BOOK
Designing Usability into Medical Products

Wiklund and Wilcox explore how to make medical devices safe and effective by involving users in the design process. They discuss specific design and evaluation methods and tools, present case studies of user-friendly medical technologies and corporate human factors programs, and supply related resources for medical design professionals. This book covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products.
By Michael E. Wiklund and Stephen B. Wilcox (382 pages)

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Practical Design Control Implementation for Medical Devices book
Practical Design Control Implementation for Medical Devices

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements by Jose Justiniano (230 pages)
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Medical Device Reliability and Associated Areas book
Medical Device Reliability and Associated Areas

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 by B.S.Dhillon, PhD (Paperback 264 pages)
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Medical Devices

European Union Policymaking and the Implementation of Health and Patient Safety in France
Medical devices and medical technology are used to create or support many different products and medical-surgical procedures.This volume on the regulation of medical devices in the European Union, with a focus on France, tackles a topic of interdisciplinary interest and significance for policymakers in countries around the globe. The EU regulatory regime is one of three global regional regimes, and medical products manufactured in EU countries are sold worldwide. By Christa Altenstetter (304 pages)
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Medical Regulatory Affairs

An International Handbook for Medical Devices and Healthcare Products
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US FDA, UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, WHO, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and BSI have contributed to the book.
By Jack Wong and Raymond Tong ( 766 pages)

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Medical Devices book entitled Medical Regulatory Affairs
Handbook of Medical Device Regulatory Affairs in Asia book
Handbook of Medical Device Regulatory Affairs in Asia

Medical device regulation in Asia has gained more importance than ever. 
This book covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. by Jack Wong (616 pages.
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Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

This book  is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. by John J. Tobin (336 pages)
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Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices book
Medical Device Quality Assurance and Regulatory Compliance

“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.” By Richard C. Fries (496 pages)
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Medical Device Quality Assurance and Regulatory Compliance
By
Richard C. Fries
Medical Device Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness book
Medical Device 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 by Susanne Manz (Paperback 294 pages)
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Validation for Medical Device and Diagnostic Manufacturers

This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of the Quality System Requirements which define the approach to medical device validation by Charmaine V. Sutton & Carol V. Desain (336 pages)
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Validation for Medical Device and Diagnostic Manufacturers book
Safety Risk Management for Medical Devices: (2nd edition) book by Bijan Elahi
Safety Risk Management for Medical Devices: (2nd edition)

teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices by Bijan Elahi  (Paperback 534 pages)
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Safety Evaluation in the Development of Medical Devices and Combination Products

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide
By Shayne C. Gad and Marian G. McCord ( 312 pages)

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Szycher’s Dictionary of Medical Devices

The field of medical devices represents one of the most advanced technological areas in the United States.The FDA maintains a constant vigil over medical device manufacturers and importers; even medical device definitions are subject to official scrutiny. Title 21 of the Code of Federal Regulations publishes these definitions, but the definitions are spread over several medical specialty areas and are, thus, difficult to find. This book attempts to bring a measure of order by providing an alphabetical listing of officially defined devices.
By Michael Szycher (Paperback 212 pages)

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