Medical Grade Software Development

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Medical-Grade Software Development

Author : ILKKA. POYHONEN JUUSO (ILPO.)
Publisher : Productivity Press
ISBN 13 : 9781032593180
Total Pages : 0 pages
Book Rating : 4.5/5 (931 download)

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Book Synopsis Medical-Grade Software Development by : ILKKA. POYHONEN JUUSO (ILPO.)

Download or read book Medical-Grade Software Development written by ILKKA. POYHONEN JUUSO (ILPO.) and published by Productivity Press. This book was released on 2023-11-13 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a practical guide to meeting IEC 62304 software development requirements within the context of an ISO 13485 quality management system (QMS). It proves it can be done with a minimum amount of friction, overlap, and back-and-forth between development stages. It essentially shows you how you should shape your medical software development processes to fit in with the QMS processes in the smartest and leanest way possible. By following the advice in this book, you can reuse processes from your QMS, ensure your product realization processes meet the requirements for medical software development, and marry all the requirements together using tried and tested solutions into one efficient system. The expertise of the authors here goes beyond just the experiences of one real-world project as they tap into over 30 years of experience and countless software and software assessment projects to distill their advice. The book takes a hands-on approach by first teaching you the top 25 lessons to know before starting to develop a process for medical software development -- It then walks you through the expectations placed on the key aspects of such a process by the key standards. The book progresses from an overview of both standards and the general requirements involved to a detailed discussion of the expected stages from software development and maintenance to risk management, configuration management, and problem resolution. The book provides insightful advice on how the requirements of the IEC 62304 software development lifecycle can be married with ISO 13485 QMS, how the development of the technical file should be organized, and how to address conformity assessment, the daily after approval, and the recent trends that will affect the industry in the coming years. The book is modeled after the IEC 62304 standard and adopts its clause structure in the numbering of sections for easy reference. The book does not attempt to replicate either standard. For the ISO 13485 standard, it recites the necessary requirements succinctly. For IEC 62304, the discussion is in-depth and also addresses the impact of ISO 13485 on the requirements discussed. In this way, the book drills into both standards to expose the core of each requirement and shape these into a practical, cohesive workflow for developing, maintaining, and improving a Lean software development pipeline.

Medical-Grade Software Development

Author : Ilkka Juuso
Publisher : CRC Press
ISBN 13 : 1000987906
Total Pages : 256 pages
Book Rating : 4.0/5 (9 download)

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Book Synopsis Medical-Grade Software Development by : Ilkka Juuso

Download or read book Medical-Grade Software Development written by Ilkka Juuso and published by CRC Press. This book was released on 2023-11-13 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a practical guide to meeting IEC 62304 software-development requirements within the context of an ISO 13485 quality management system (QMS). The book proves this can be done with a minimum amount of friction, overlap, and back-and-forth between development stages. It essentially shows you how you should shape your medical-software development processes to fit in with the QMS processes in the smartest and leanest way possible. By following the advice in this book, you can reuse processes from your QMS, ensure your product-realization processes meet the requirements for medical-software development, and marry all the requirements together using tried and tested solutions into one efficient system. The expertise of the authors here goes beyond just the experiences of one real-world project as they tap into over 30 years of experience and countless software and software-assessment projects to distill their advice. The book takes a hands-on approach by first teaching you the top 25 lessons to know before starting to develop a process for medical-software development. It then walks you through the expectations placed on the key aspects of such a process by the key standards. The book progresses from an overview of both standards and the general requirements involved to a detailed discussion of the expected stages from software development and maintenance to risk management, configuration management, and problem resolution. The book provides insightful advice on how the requirements of the IEC 62304 software-development life cycle can be married with an ISO 13485 QMS, how the development of the technical file should be organized, and how to address conformity assessment, the daily after-approval, and the recent trends that will affect the industry in the coming years. The book is modeled after the IEC 62304 standard and adopts its clause structure in the numbering of sections for easy reference. The book does not attempt to replicate either standard. For the ISO 13485 standard, it recites the necessary requirements succinctly. For IEC 62304, the discussion is in-depth and also addresses the impact of ISO 13485 on the requirements discussed. In this way, the book drills into both standards to expose the core of each requirement and shape these into a practical, cohesive workflow for developing, maintaining, and improving a Lean software development pipeline.

Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations

Author : Philip S. Cosgriff
Publisher : CRC Press
ISBN 13 : 1040002358
Total Pages : 223 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations by : Philip S. Cosgriff

Download or read book Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations written by Philip S. Cosgriff and published by CRC Press. This book was released on 2024-03-26 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house. It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations. This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice. Key Features: Up to date with the latest regulations in the UK, the EU, and the US Useful for those producing medical software for routine clinical use Contains best practice

Introduction to Medical Software

Author : Xenophon Papademetris
Publisher : Cambridge University Press
ISBN 13 : 1316514994
Total Pages : 341 pages
Book Rating : 4.3/5 (165 download)

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Book Synopsis Introduction to Medical Software by : Xenophon Papademetris

Introduction to Medical Software

Author : Xenophon Papademetris
Publisher : Cambridge University Press
ISBN 13 : 1009090143
Total Pages : 342 pages
Book Rating : 4.0/5 (9 download)

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Book Synopsis Introduction to Medical Software by : Xenophon Papademetris

Download or read book Introduction to Medical Software written by Xenophon Papademetris and published by Cambridge University Press. This book was released on 2022-05-05 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing a concise and accessible overview of the design, implementation and management of medical software, this textbook will equip students with a solid understanding of critical considerations for both standalone medical software (software as a medical device/SaMD) and software that is integrated into hardware devices. It includes: practical discussion of key regulatory documents and industry standards, and how these translate into concrete considerations for medical software design; detailed coverage of the medical software lifecycle process ; accessible introduction to quality and risk management systems in the context of medical software; succinct coverage of essential topics in data science, machine learning, statistics, cybersecurity, software engineering and healthcare bring readers up-to-speed; six cautionary real-world case studies illustrate the dangers of improper or careless software processes. Accompanied by online resources for instructors, this is the ideal introduction for undergraduate students in biomedical engineering, electrical engineering and computer science, junior software engineers, and digital health entrepreneurs.

Developing an ISO 13485-Certified Quality Management System

Author : Ilkka Juuso
Publisher : CRC Press
ISBN 13 : 1000550680
Total Pages : 331 pages
Book Rating : 4.0/5 (5 download)

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Book Synopsis Developing an ISO 13485-Certified Quality Management System by : Ilkka Juuso

Download or read book Developing an ISO 13485-Certified Quality Management System written by Ilkka Juuso and published by CRC Press. This book was released on 2022-03-20 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects. In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS.

Engineering High Quality Medical Software

Author : Antonio Coronato
Publisher :
ISBN 13 : 9781523115358
Total Pages : 297 pages
Book Rating : 4.1/5 (153 download)

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Book Synopsis Engineering High Quality Medical Software by : Antonio Coronato

Download or read book Engineering High Quality Medical Software written by Antonio Coronato and published by . This book was released on 2018 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on high-confidence medical software in the growing field of e-health, telecare services and health technology. It covers the development of methodologies and engineering tasks together with standards and regulations for medical software.

Integrating Device Data into the Electronic Medical Record

Author : John Zaleski
Publisher : John Wiley & Sons
ISBN 13 : 3895786322
Total Pages : 354 pages
Book Rating : 4.8/5 (957 download)

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Book Synopsis Integrating Device Data into the Electronic Medical Record by : John Zaleski

Download or read book Integrating Device Data into the Electronic Medical Record written by John Zaleski and published by John Wiley & Sons. This book was released on 2008-12-23 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: Future generations of vital signs and point-of-care medical devices must interoperate directly and seamlessly with information technology systems to facilitate effective patient care management within the healthcare enterprise. This is the first book addressing medical device integration with the computer-based patient record in a holistic way. Readers step into the area of two-way device communication & control and learn best practises from an author known for his brilliant expertise in this field. It is a fundamental guide for a broad group of people: clinical and biomedical engineers, physicians, bioinformatics practitioners, and vendors. Providing the essential how-to for medical device integration into the electronic medical record (EMR), health information system (HIS), and computerized patient record (CPR), the book highlights information on data extraction, usually not offered by device vendors. This comprises topics such as the use of third-party software, information on what to do when you develop interfaces on your own, regulatory issues, and how to assure connectivity and access to data. For physicians, it is a primer and knowledge manual for data integration when applied to clinical care and trials. It gives information on knowledge management and how data can be used statistically and as a tool in patient care management. Furthermore, it impresses upon the reader the quantities of data that must be processed and reduced to make for effective use at the point of care. HIS and CPR vendors may learn how data integration can be simplified and how software developers may be assisted in the process of communicating vital information to their repositories. The book is rounded off by a chapter on the future of integration.

Reliable Design of Medical Devices

Author : Richard C. Fries
Publisher :
ISBN 13 : 9781523129843
Total Pages : 0 pages
Book Rating : 4.1/5 (298 download)

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Book Synopsis Reliable Design of Medical Devices by : Richard C. Fries

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by . This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The medical device industry is constantly changing; as a result, texts regarding the reliability of these devices must keep pace with changes. With an emphasis on safety and analysis of hazards and risks, this third edition addresses changes in software methodology and discusses the latest thinking on software reliability. 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. 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.

Developing an ISO 13485-Certified Quality Management System

Author : Ilkka Juuso
Publisher : CRC Press
ISBN 13 : 1000550664
Total Pages : 371 pages
Book Rating : 4.0/5 (5 download)

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Book Synopsis Developing an ISO 13485-Certified Quality Management System by : Ilkka Juuso

Download or read book Developing an ISO 13485-Certified Quality Management System written by Ilkka Juuso and published by CRC Press. This book was released on 2022-03-20 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects. In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS.

Software Engineering in Health Care

Author : Michaela Huhn
Publisher : Springer
ISBN 13 : 3319631942
Total Pages : 249 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis Software Engineering in Health Care by : Michaela Huhn

Download or read book Software Engineering in Health Care written by Michaela Huhn and published by Springer. This book was released on 2017-07-26 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes revised selected papers from the jointly held conferences FHIES 2014, 4th International Symposium on Foundations of Health Information Engineering and Systems, and SEHC 2014, 6th International Workshop on Software Engineering in Health Care. The meeting took place in Washington, DC, USA, in July 2014. The 16 papers presented in this volume were carefully reviewed and selected from 23 submissions. They deal with security aspects of health information systems; medical devices in cyberphysical systems; the process of providing healthcare and of monitoring patients; and patient safety and the assurance of medical systems.

Agile Methods for Safety-Critical Systems

Author : Nancy Van Schooenderwoert
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781717543141
Total Pages : 130 pages
Book Rating : 4.5/5 (431 download)

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Book Synopsis Agile Methods for Safety-Critical Systems by : Nancy Van Schooenderwoert

Download or read book Agile Methods for Safety-Critical Systems written by Nancy Van Schooenderwoert and published by Createspace Independent Publishing Platform. This book was released on 2018-06-04 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book, packed with real-world insights and direct experiences, is for managers who want the benefits of Agile but also must address regulatory compliance, integration of software with other disciplines, and product safety. In it, we combine our understanding of Agile development, hardware/software integration, and regulatory requirements. We know that Agile is simple but not easy; leadership is crucial to make this change spread. We aim to show how you can navigate the transition.

Writing In-House Medical Device Software in Compliance with Eu, Uk, and Us Regulations

Author : PHILIP S.. MEMMOTT COSGRIFF (MATTHEW.)
Publisher :
ISBN 13 : 9781032293486
Total Pages : 0 pages
Book Rating : 4.2/5 (934 download)

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Book Synopsis Writing In-House Medical Device Software in Compliance with Eu, Uk, and Us Regulations by : PHILIP S.. MEMMOTT COSGRIFF (MATTHEW.)

Download or read book Writing In-House Medical Device Software in Compliance with Eu, Uk, and Us Regulations written by PHILIP S.. MEMMOTT COSGRIFF (MATTHEW.) and published by . This book was released on 2024-03-26 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house. It compares the latest regulatory requirements in different global territories, including the most recent EU regulations as well as current UK and US regulations. This book is a valuable resource for practicing clinical scientists producing medical software in-house, as well as clinical scientist trainees, tech-savvy medical staff, and software engineers considering a move into healthcare. The academic level is post-graduate, and readers will require a basic knowledge of software engineering principles and practice. Key Features: Up to date with the latest regulations in the UK, EU, and US. Useful for those producing medical software for routine clinical use. Contains best practice. Philip Cosgriff worked as a clinical scientist in the UK National Health Service for nearly 40 years, specialising mainly in nuclear medicine. He produced in-house data analysis software during that whole period, with an emphasis on software quality assurance. He was a UK delegate on a pioneering EU project (COST-B2) on quality assurance of nuclear medicine software and he has contributed to numerous quality assurance reports published by the UK Institute of Physics and Engineering in Medicine (IPEM). He was the first recipient of the IPEM Healthcare Gold Medal in 2016. He is a recognised expert on the application of EU and UK medical device legislation, as well as other consumer protection legislation that may affect the in-house medical software developer. His current interests include the application of AI technologies to diagnostic imaging and the future role of medical apps.

Medical Device Design

Author : Peter J. Ogrodnik
Publisher : Academic Press
ISBN 13 : 0128149639
Total Pages : 538 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Medical Device Design by : Peter J. Ogrodnik

Download or read book Medical Device Design written by Peter J. Ogrodnik and published by Academic Press. This book was released on 2019-10-30 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Design: Innovation from Concept to Market, Second Edition 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; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns

Advances in technology for the sleep field, An Issue of Sleep Medicine Clinics, E-Book

Author : Steven Holfinger
Publisher : Elsevier Health Sciences
ISBN 13 : 0443182418
Total Pages : 145 pages
Book Rating : 4.4/5 (431 download)

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Book Synopsis Advances in technology for the sleep field, An Issue of Sleep Medicine Clinics, E-Book by : Steven Holfinger

Download or read book Advances in technology for the sleep field, An Issue of Sleep Medicine Clinics, E-Book written by Steven Holfinger and published by Elsevier Health Sciences. This book was released on 2023-08-03 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this issue of Sleep Medicine Clinics, guest editor Dr. Steven Holfinger brings his considerable expertise to the topic of Advances in Technology for the Sleep Field. Top experts discuss current development and use of multi-modal sensors and technologies which make accurate sleep monitoring at scale a possibility in today’s sleep medicine. Contains 15 practice-oriented topics including using telehealth platforms to transform sleep care models; are consumer wearable sleep trackers ready for clinical use; potential implications of screen time in an age of augmented/virtual reality; advancements in sleep health to optimize human performance; and more. Provides in-depth clinical reviews of advances in technology for the sleep field, offering actionable insights for clinical practice. Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create clinically significant, topic-based reviews.

Medical Device Register

Author :
Publisher :
ISBN 13 :
Total Pages : 1692 pages
Book Rating : 4.:/5 (318 download)

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Book Synopsis Medical Device Register by :

Download or read book Medical Device Register written by and published by . This book was released on 2007 with total page 1692 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contains a list of all manufacturers and other specified processors of medical devices registered with the Food and Drug Administration, and permitted to do business in the U.S., with addresses and telephone numbers. Organized by FDA medical device name, in alphabetical order. Keyword index to FDA established standard names of medical devices.

Medical Device Software. Software Life-cycle Processes

Author : British Standards Institute Staff
Publisher :
ISBN 13 : 9780580496592
Total Pages : 80 pages
Book Rating : 4.4/5 (965 download)

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Book Synopsis Medical Device Software. Software Life-cycle Processes by : British Standards Institute Staff

Download or read book Medical Device Software. Software Life-cycle Processes written by British Standards Institute Staff and published by . This book was released on 2006-11 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt: Electrical medical equipment, Electrical equipment, Medical equipment, Computer software, Life (durability), Design, Maintenance, Equipment safety, Safety measures, Hazards, Software engineering techniques, Computer technology, Quality management, Risk assessment, Identification methods, Quality assurance systems