The Medical Device Engineers Handbook

The Medical Device Engineers Handbook PDF Author: Emmet Tobin
Publisher:
ISBN: 9781534783195
Category :
Languages : en
Pages : 262

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Book Description
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)

The Medical Device Engineers Handbook

The Medical Device Engineers Handbook PDF Author: Emmet Tobin
Publisher:
ISBN: 9781534783195
Category :
Languages : en
Pages : 262

Get Book

Book Description
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)

Medical Devices and Human Engineering

Medical Devices and Human Engineering PDF Author: Joseph D. Bronzino
Publisher: CRC Press
ISBN: 1439825262
Category : Medical
Languages : en
Pages : 891

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Book Description
Known as the bible of biomedical engineering, The Biomedical Engineering Handbook, Fourth Edition, sets the standard against which all other references of this nature are measured. As such, it has served as a major resource for both skilled professionals and novices to biomedical engineering. Medical Devices and Human Engineering, the second volume of the handbook, presents material from respected scientists with diverse backgrounds in biomedical sensors, medical instrumentation and devices, human performance engineering, rehabilitation engineering, and clinical engineering. More than three dozen specific topics are examined, including optical sensors, implantable cardiac pacemakers, electrosurgical devices, blood glucose monitoring, human–computer interaction design, orthopedic prosthetics, clinical engineering program indicators, and virtual instruments in health care. The material is presented in a systematic manner and has been updated to reflect the latest applications and research findings.

Clinical Engineering Handbook

Clinical Engineering Handbook PDF Author: Joseph F. Dyro
Publisher: Academic Press
ISBN: 012226570X
Category : Medical
Languages : en
Pages : 696

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Book Description
As the biomedical engineering field expands throughout the world, clinical engineers play an ever more important role as the translator between the worlds of the medical, engineering, and business professionals. They influence procedure and policy at research facilities, universities and private and government agencies including the Food and Drug Administration and the World Health Organization. Clinical engineers were key players in calming the hysteria over electrical safety in the 1970s and Y2K at the turn of the century and continue to work for medical safety. This title brings together all the important aspects of Clinical Engineering. It provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world.

Clinical Engineering Handbook

Clinical Engineering Handbook PDF Author: Ernesto Iadanza
Publisher: Academic Press
ISBN: 0128134682
Category : Technology & Engineering
Languages : en
Pages : 960

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Book Description
Clinical Engineering Handbook, Second Edition, covers modern clinical engineering topics, giving experienced professionals the necessary skills and knowledge for this fast-evolving field. Featuring insights from leading international experts, this book presents traditional practices, such as healthcare technology management, medical device service, and technology application. In addition, readers will find valuable information on the newest research and groundbreaking developments in clinical engineering, such as health technology assessment, disaster preparedness, decision support systems, mobile medicine, and prospects and guidelines on the future of clinical engineering.As the biomedical engineering field expands throughout the world, clinical engineers play an increasingly important role as translators between the medical, engineering and business professions. In addition, they influence procedures and policies at research facilities, universities, and in private and government agencies. This book explores their current and continuing reach and its importance. Presents a definitive, comprehensive, and up-to-date resource on clinical engineering Written by worldwide experts with ties to IFMBE, IUPESM, Global CE Advisory Board, IEEE, ACCE, and more Includes coverage of new topics, such as Health Technology Assessment (HTA), Decision Support Systems (DSS), Mobile Apps, Success Stories in Clinical Engineering, and Human Factors Engineering

The Medical Device R&D Handbook

The Medical Device R&D Handbook PDF Author: Theodore R. Kucklick
Publisher: CRC Press
ISBN: 1420038354
Category : Medical
Languages : en
Pages : 376

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Book Description
The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha

Medical Devices and Systems

Medical Devices and Systems PDF Author: Joseph D. Bronzino
Publisher: CRC Press
ISBN: 1420003860
Category : Medical
Languages : en
Pages : 1404

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Book Description
Over the last century, medicine has come out of the "black bag" and emerged as one of the most dynamic and advanced fields of development in science and technology. Today, biomedical engineering plays a critical role in patient diagnosis, care, and rehabilitation. More than ever, biomedical engineers face the challenge of making sure that medical d

The Biomedical Engineering Handbook

The Biomedical Engineering Handbook PDF Author: Joseph D. Bronzino
Publisher: CRC Press
ISBN: 1439863113
Category : Medical
Languages : en
Pages : 5430

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Book Description
The definitive "bible" for the field of biomedical engineering, this collection of volumes is a major reference for all practicing biomedical engineers and students. Now in its fourth edition, this work presents a substantial revision, with all sections updated to offer the latest research findings. New sections address drugs and devices, personali

Medical Device Cybersecurity for Engineers and Manufacturers

Medical Device Cybersecurity for Engineers and Manufacturers PDF Author: Axel Wirth
Publisher: Artech House
ISBN: 163081816X
Category : Computers
Languages : en
Pages : 270

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Book Description
Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed with urgency. In the end, this is about preventing patient harm and preserving patient trust. A comprehensive guide to medical device secure lifecycle management, this is a book for engineers, managers, and regulatory specialists. Readers gain insight into the security aspects of every phase of the product lifecycle, including concept, design, implementation, supply chain, manufacturing, postmarket surveillance, maintenance, updates, and end of life. Learn how to mitigate or completely avoid common cybersecurity vulnerabilities introduced during development and production. Grow your awareness of cybersecurity development topics ranging from high-level concepts to practical solutions and tools. Get insight into emerging regulatory and customer expectations. Uncover how to minimize schedule impacts and accelerate time-to-market while still accomplishing the main goal: reducing patient and business exposure to cybersecurity risks. Medical Device Cybersecurity for Engineers and Manufacturers is designed to help all stakeholders lead the charge to a better medical device security posture and improve the resilience of our medical device ecosystem.

Medical Device Design

Medical Device Design PDF Author: Peter J Ogrodnik
Publisher: Academic Press
ISBN: 0123919436
Category : Technology & Engineering
Languages : en
Pages : 376

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Book Description
This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Human resources for medical devices - the role of biomedical engineers

Human resources for medical devices - the role of biomedical engineers PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 9789241565479
Category : Medical
Languages : en
Pages : 0

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Book Description
This publication addresses the role of the biomedical engineer in the development, regulation, management, training, and use of medical devices. The first part of the book looks at the biomedical engineering profession globally as part of the health workforce: global numbers and statistics, professional classification, general education and training, professional associations, and the certification process. The second part addresses all of the different roles that the biomedical engineer can have in the life cycle of the technology, from research and development, and innovation, mainly undertaken in academia; the regulation of devices entering the market; and the assessment or evaluation in selecting and prioritizing medical devices (usually at national level); to the role they play in the management of devices from selection and procurement to safe use in healthcare facilities. The annexes present comprehensive information on academic programs, professional societies, and relevant WHO and UN documents related to human resources for health as well as the reclassification proposal for ILO. This publication can be used to encourage the availability, recognition, and increased participation of biomedical engineers as part of the health workforce, particularly following the recent adoption of the recommendations of the UN High-Level Commission on Health Employment and Economic Growth, the WHO Global Strategy on Human Resources for Health, and the establishment of national health workforce accounts. The document also supports the aim of reclassification of the role of the biomedical engineer as a specific engineer that supports the development, access, and use of medical devices within the national, regional, and global occupation classification system.