Statistical Procedures for the Medical Device Industry
Author : Wayne A. Taylor
Publisher :
Page : 0 pages
File Size : 34,97 MB
Release : 2017
Category :
ISBN : 9780963512291
Author : Wayne A. Taylor
Publisher :
Page : 0 pages
File Size : 34,97 MB
Release : 2017
Category :
ISBN : 9780963512291
Author : Xenophon Papademetris
Publisher : Cambridge University Press
Page : 341 pages
File Size : 16,68 MB
Release : 2022-05-05
Category : Business & Economics
ISBN : 1316514994
A concise and accessible overview of the design, implementation and management of medical software.
Author : Roger L. Brauer
Publisher : John Wiley & Sons
Page : 678 pages
File Size : 19,30 MB
Release : 2022-08-18
Category : Technology & Engineering
ISBN : 1119802318
SAFETY AND HEALTH FOR ENGINEERS A comprehensive resource for making products, facilities, processes, and operations safe for workers, users, and the public Ensuring the health and safety of individuals in the workplace is vital on an interpersonal level but is also crucial to limiting the liability of companies in the event of an onsite injury. The Bureau of Labor Statistics reported over 4,700 fatal work injuries in the United States in 2020, most frequently in transportation-related incidents. The same year, approximately 2.7 million workplace injuries and illnesses were reported by private industry employers. According to the National Safety Council, the cost in lost wages, productivity, medical and administrative costs is close to 1.2 trillion dollars in the US alone. It is imperative—by law and ethics—for engineers and safety and health professionals to drive down these statistics by creating a safe workplace and safe products, as well as maintaining a safe environment. Safety and Health for Engineers is considered the gold standard for engineers in all specialties, teaching an understanding of many components necessary to achieve safe workplaces, products, facilities, and methods to secure safety for workers, users, and the public. Each chapter offers information relevant to help safety professionals and engineers in the achievement of the first canon of professional ethics: to protect the health, safety, and welfare of the public. The textbook examines the fundamentals of safety, legal aspects, hazard recognition and control, the human element, and techniques to manage safety decisions. In doing so, it covers the primary safety essentials necessary for certification examinations for practitioners. Readers of the fourth edition of Safety and Health for Engineers readers will also find: Updates to all chapters, informed by research and references gathered since the last publication The most up-to-date information on current policy, certifications, regulations, agency standards, and the impact of new technologies, such as wearable technology, automation in transportation, and artificial intelligence New international information, including U.S. and foreign standards agencies, professional societies, and other organizations worldwide Expanded sections with real-world applications, exercises, and 164 case studies An extensive list of references to help readers find more detail on chapter contents A solution manual available to qualified instructors Safety and Health for Engineers is an ideal textbook for courses in safety engineering around the world in undergraduate or graduate studies, or in professional development learning. It also is a useful reference for professionals in engineering, safety, health, and associated fields who are preparing for credentialing examinations in safety and health.
Author : Stephen H. Kan
Publisher : Addison-Wesley Professional
Page : 564 pages
File Size : 44,48 MB
Release : 2003
Category : Computers
ISBN : 9780201729153
""This is the single best book on software quality engineering and metrics that I've encountered."" --Capers Jones, from the Foreword"Metrics and Models in Software Quality Engineering, Second Edition," is the definitive book on this essential topic of software development. Comprehensive in scope with extensive industry examples, it shows how to measure software quality and use measurements to improve the software development process. Four major categories of quality metrics and models are addressed: quality management, software reliability and projection, complexity, and customer view. In addition, the book discusses the fundamentals of measurement theory, specific quality metrics and tools, and methods for applying metrics to the software development process.New chapters bring coverage of critical topics, including: In-process metrics for software testingMetrics for object-oriented software developmentAvailability metricsMethods for conducting in-process quality assessments and software project assessmentsDos and Don'ts of Software Process Improvement, by Patrick O'TooleUsing Function Point Metrics to Measure Software Process Improvement, by Capers Jones In addition to the excellent balance of theory, techniques, and examples, this book is highly instructive and practical, covering one of the most important topics in software development--quality engineering. 0201729156B08282002
Author : Philip S. Cosgriff
Publisher : CRC Press
Page : 223 pages
File Size : 47,15 MB
Release : 2024-03-26
Category : Science
ISBN : 1040002358
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
Author : Linda Westfall
Publisher : Quality Press
Page : 1050 pages
File Size : 12,30 MB
Release : 2016-09-23
Category : Computers
ISBN : 195105878X
This handbook contains information and guidance that supports all of the topics of the 2016 version of the CSQE Body of Knowledge (BoK) upon which ASQ's Certified Software Quality Engineer/(CSQE) exam is based. Armed with the knowledge presented in this handbook to complement the required years of actual work experience, qualified software quality practitioners may feel confident they have taken appropriate steps in preparation for the ASQ CSQE exam. However, the goals for this handbook go well beyond it being a CSQE exam preparation guide. Its author designed this handbook not only to help the software quality engineers, but as a resource for software development practitioners, project managers, organizational managers, other quality practitioners, and other professionals who need to understand the aspects of software quality that impact their work. It can also be used to benchmark their (or their organization's) understanding and application of software quality principles and practices against what is considered a cross-industry good practice baseline. After all, taking stock of strengths and weaknesses, software engineers can develop proactive strategies to leverage software quality as a competitive advantage. New software quality engineers can use this handbook to gain an understanding of their chosen profession. Experienced software quality engineers can use this handbook as a reference source when performing their daily work. It is also hoped that trainers and educators will use this handbook to help propagate software quality engineering knowledge to future software practitioners and managers. Finally, this handbook strives to establish a common vocabulary that software quality engineers, and others in their organizations can use to communicate about software and quality. Thus increasing the professionalism of the industry and eliminating the wastes that can result from ambiguity and misunderstandings.
Author : Murat Yilmaz
Publisher : Springer Nature
Page : 753 pages
File Size : 16,6 MB
Release : 2021-08-26
Category : Business & Economics
ISBN : 303085521X
This volume constitutes the refereed proceedings of the 28th European Conference on Systems, Software and Services Process Improvement, EuroSPI 2021, held in Krems, Austria, in September 2021*. The 42 full papers and 9 short papers presented were carefully reviewed and selected from 100 submissions. The volume presents core research contributions and selected industrial contributions. Core research contributions: SPI and emerging software and systems engineering paradigms; SPI and team skills and diversity; SPI and recent innovations; SPI and agile; SPI and standards and safety and security norms; SPI and good/bad SPI practices in improvement; SPI and functional safety and cybersecurity; digitalisation of industry, infrastructure and e-mobility. Selected industrial contributions: SPI and emerging software and systems engineering paradigms; SPI and recent innovations; SPI and agile; SPI and standards and safety and security norms; SPI and good/bad SPI practices in improvement; SPI and functional safety and cybersecurity; digitalisation of industry, infrastructure and e-mobility; virtual reality. *The conference was partially held virtually due to the COVID-19 pandemic.
Author : Axel Wirth
Publisher : Artech House
Page : 303 pages
File Size : 44,52 MB
Release : 2020-08-31
Category : Computers
ISBN : 163081816X
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.
Author : Christian Baumgartner
Publisher : Springer Nature
Page : 671 pages
File Size : 38,60 MB
Release : 2023-08-26
Category : Technology & Engineering
ISBN : 3031220919
This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries.
Author : Lee Copeland
Publisher : Artech House
Page : 328 pages
File Size : 17,75 MB
Release : 2004
Category : Computers
ISBN : 9781580537322
Written by a leading expert in the field, this unique volume contains current test design approaches and focuses only on software test design. Copeland illustrates each test design through detailed examples and step-by-step instructions.