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Showing 1 - 9 of 9 matches in All departments

Handbook of Medical Device Design (Hardcover): Richard C. Fries Handbook of Medical Device Design (Hardcover)
Richard C. Fries
R6,211 Discovery Miles 62 110 Shipped within 7 - 12 working days

Compiling an abundant catalog of the essential criteria and methods for the design of medical devices, this comprehensive reference supplies insights into a rapidly evolving field-spanning practical knowledge, field tracking, valuable timesaving techniques, and the latest innovations. Reviews current regulatory and standards issues, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives Foreseeing a variety of concerns and obstacles, the Handbook of Medical Device Design identifies how to determine and document customer needs and device requirements establishes reliability and quality metrics for the duration of the product development cycle compares international regulations and standards, in Europe, Canada, Japan, and Australia illustrates electrical, mechanical, hardware, software, and industrial design considerations discusses biocompatibility, safety/risk analysis, third-party certification, technical documentation, translations, and life-cycle costs of implantable equipment thoroughly examines manufacturing processes such as quality system regulation and preparation for the quality system audit and more Includes useful appendices of tables and a glossary Written by experienced practitioners and authorities in the field, the Handbook of Medical Device Design is a necessary and worthwhile reference and guidebook for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project managers; biomedical technicians, medical device purchasing personnel; and upper-level undergraduate and graduate students in these disciplines.

Medical Device Quality Assurance and Regulatory Compliance (Hardcover, illustrated edition): Richard C. Fries Medical Device Quality Assurance and Regulatory Compliance (Hardcover, illustrated edition)
Richard C. Fries
R4,945 Discovery Miles 49 450 Shipped within 7 - 12 working days

This essential reference 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 Assurance and Regulatory Compliance summarizes regulation activities of the FDA, the European Economic Community, and the Global Harmonization Task Force shows how to choose a standard from the ISO 9000 and ISO 14000 series teaches how to prepare your company for auditing, how to choose a notified body, and how to survive the audit reviews standards dealing specifically with medical devices such as EN 46000, ISO 13485, and ISO 13488 discusses the requirements for product submittals prior to product introduction addresses current issues such as third party approvals and more Including numerous key references, tables, and drawings, Medical Device Quality Assurance and Regulatory Compliance is ideal for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project managers; biomedical technicians; medical device purchasing personnel; and upper-level undergraduate and graduate students in these disciplines.

Design of Biomedical Devices and Systems, 4th edition (Hardcover, 4th New edition): Paul H. King, Richard C. Fries, Arthur T.... Design of Biomedical Devices and Systems, 4th edition (Hardcover, 4th New edition)
Paul H. King, Richard C. Fries, Arthur T. Johnson
R2,560 Discovery Miles 25 600 Shipped within 7 - 12 working days

This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer's work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes

Reliable Design of Medical Devices (Hardcover, 3rd New edition): Richard C. Fries Reliable Design of Medical Devices (Hardcover, 3rd New edition)
Richard C. Fries
R4,662 Discovery Miles 46 620 Special order

As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What's New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author's more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program-contributing to increased profitability, more satisfied customers, and less risk of liability.

Design of Biomedical Devices and Systems, Second Edition (Loose-leaf): Paul King, Richard C. Fries Design of Biomedical Devices and Systems, Second Edition (Loose-leaf)
Paul King, Richard C. Fries
R2,520 Discovery Miles 25 200 Special order

Analyzing product conception through delivery in actual industry examples, this text considers issues in the industrial design process exactly as they would arise in real-world applications, divulging valuable trade secrets within topics like materials selection, safety, prototyping, premarket testing and validation, liability, and learning from failure. The authors discuss product definition, development, marketing, verification, and validation, elucidate the QFD process, and address engineering licensure and codes of ethics. They also introduce new concepts in hardware and software design, including the use of computer tools to predict and document safety-related design issues.

Design of Biomedical Devices and Systems, Second Edition (Loose-leaf, 2nd ed.): Paul King, Richard C. Fries Design of Biomedical Devices and Systems, Second Edition (Loose-leaf, 2nd ed.)
Paul King, Richard C. Fries
R2,508 Discovery Miles 25 080 Special order

The design and functional complexity of medical devices have increased over the past 50 years, evolving from cardiac pacemakers to magnetic resonance imaging. Design of Biomedical Devices and Systems provides a comprehensive overview of this area - including topics related to databases, process analysis, and device improvement - from a strong design perspective. Aimed at senior undergraduates, this text covers all aspects of design that must be considered for complex biomedical projects. This new second edition features additional information on device definition and reliability, as well as testing and hardware verification. All chapters are updated to reflect the latest advances in the field.

Handbook of Medical Device Design (Hardcover): Richard C. Fries Handbook of Medical Device Design (Hardcover)
Richard C. Fries
R3,945 Discovery Miles 39 450 Special order
Reliable Design of Medical Devices (Paperback, 3rd New edition): Richard C. Fries Reliable Design of Medical Devices (Paperback, 3rd New edition)
Richard C. Fries
R1,831 Discovery Miles 18 310 Special order

As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What's New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author's more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program-contributing to increased profitability, more satisfied customers, and less risk of liability.

Medical Device Quality Assurance and Regulatory Compliance (Paperback): Richard C. Fries Medical Device Quality Assurance and Regulatory Compliance (Paperback)
Richard C. Fries
R1,268 Discovery Miles 12 680 Special order
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