Risk Management for Medical Device Manufacturers
Risk Management for Medical Device Manufacturers

Author: Joe W. Simon

Publisher: Quality Press

Published: 2022-01-20

Total Pages: 251

ISBN-13: 1636940145

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As a quality professional in the medical device industry, you know all too well the importance of a risk management process-and how iterative it can be. Industry regulations and standards-like ISO 14971-help medical device manufacturers define risk management processes, but they don't make them bulletproof, that is, ensure the efficacy of their products while minimizing future liability. This book can help you build a bulletproof, risk process. You will learn how: Designing product and manufacturing processes controls risks Using consistent language in a holistic, closed-loop risk management system leads to greater efficiency Creating useable and audit-ready risk documents can support verification/validation (V/V) sampling plans Developing labels and instructions can help end-users and patients clearly understand the pertinent risks Creating post-market surveillance (PMS) processes is essential to determine if additional clinical/performance studies are necessary Joe Simon holds an MBA and has been a member of ASQ since 2008. Over his nearly 30-year career, he worked with numerous companies as an employee and a consultant to build or improve complaint analysis, trending, post-market surveillance (PMS), nonconformance (NC), corrective action/preventive action (CAPA), stewardship, and risk management processes.

Materials for Medical Application
Materials for Medical Application

Author: Robert B. Heimann

Publisher: Walter de Gruyter GmbH & Co KG

Published: 2020-08-24

Total Pages: 638

ISBN-13: 3110619245

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This book gives an introduction to the highly interdisciplinary field of biomaterials. It concisely summarizes properties, synthesis and modification of materials such as metals, ceramics, polymers or composites. Characterization, in vitro and in vivo testing as well as a selection of various applications are also part of this inevitable guide.

Risk Assessment and Risk-Driven Testing
Risk Assessment and Risk-Driven Testing

Author: Fredrik Seehusen

Publisher: Springer

Published: 2015-11-12

Total Pages: 125

ISBN-13: 3319264168

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This book constitutes the thoroughly refereed conference proceedings of the Third International Workshop on Risk Assessment and Risk-driven Testing, RISK 2015, held in conjunction with the OMG Technical Meeting in Berlin, Germany, in June 2015. The revised 8 full papers were carefully reviewed and selected from 12 submissions. This workshop addresses systematic approaches that combine risk assessment and testing. Also, the workshop was structured into the three sessions namely Risk Assessment, Risk and Development and Security Testing.

Excellence Beyond Compliance
Excellence Beyond Compliance

Author: William I. White

Publisher: Taylor & Francis

Published: 2018-05-16

Total Pages: 222

ISBN-13: 1351032569

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Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation. This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful. After a review of the challenges that any medical device company faces in the world of today—the multiple sources of QMS requirements—the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help. This book offers: Advice that will lead to an effective and efficient QMS. Detailed guidance on the key decisions to be made regarding the quality system being established. Detailed ideas on how to execute those decisions. Up-to-date information on compliance to current regulations and standards and guidance on staying up to date. Specific examples of procedures. Information regarding requirements for combination products, such as a drug + device combination. Advice on incorporating risk management in the QMS.

Quality of Information and Communications Technology
Quality of Information and Communications Technology

Author: Martin Shepperd

Publisher: Springer Nature

Published: 2020-08-31

Total Pages: 506

ISBN-13: 3030587932

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This book constitutes the refereed proceedings of the 13th International Conference on the Quality of Information and Communications Technology, QUATIC 2020, held in Faro, Portugal*, in September 2020. The 27 full papers and 12 short papers were carefully reviewed and selected from 81 submissions. The papers are organized in topical sections: quality aspects in machine learning, AI and data analytics; evidence-based software quality engineering; human and artificial intelligences for software evolution; process modeling, improvement and assessment; software quality education and training; quality aspects in quantum computing; safety, security and privacy; ICT verification and validation; RE, MDD and agile. *The conference was held virtually due to the COVID-19 pandemic.

Foundations of Health Information Engineering and Systems
Foundations of Health Information Engineering and Systems

Author: Jeremy Gibbons

Publisher: Springer

Published: 2014-01-09

Total Pages: 299

ISBN-13: 3642539564

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This book constitutes the thoroughly refereed post-conference proceedings of the Third International Symposium on Foundations of Health Information Engineering and Systems, FHIES 2013, held in Macau, China, in August 2013. The 19 revised full papers presented together with 1 invited talk in this volume were carefully reviewed and selected from 22 submissions. The papers are organized in following subjects: panel position statements, pathways, generation and certification, interoperability, patient safety, device safety, formal methods and HIV/AIDS and privacy.

Software Process Improvement and Capability Determination
Software Process Improvement and Capability Determination

Author: Paul M. Clarke

Publisher: Springer

Published: 2016-05-11

Total Pages: 447

ISBN-13: 3319389807

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This book constitutes the refereed proceedings of the 16th International Conference on Software Process Improvement and Capability Determination, SPICE 2016, held in Dublin, Ireland, in June 2016. The 28 full papers presented together with 5 short papers were carefully reviewed and selected from 52 submissions. The papers are organized in the following topical sections: SPI in regulated and safety critical domains; gamification and education issues in SPI; SPI in agile and small settings; SPI and assessment; SPI and project management concerns; empirical research case studies of SPI; knowledge and human communications issues in SPI.

Usability, Accessibility and Ambient Assisted Living
Usability, Accessibility and Ambient Assisted Living

Author: Alexandra Queirós

Publisher: Springer

Published: 2019-01-21

Total Pages: 106

ISBN-13: 3319912267

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Worldwide, the population ageing is a reality. The concept of Active Ageing, adopted by the World Health Organization, aims to guarantee quality ageing and appears as a strategy to solve this demographic challenge. The technological solutions might have a key role in the promotion of human functioning and in the mitigation of disabilities, particularly those resulting from the natural ageing process. This perspective is evident in the development of Ambient Assisted Living (AAL) solutions. In this context, it is relevant to know about the recent developments in AAL and discuss future trends and challenges in this area. One of the objectives of this book is to do a systematic literature review on AAL, not only considering the technology used, but also the health condition that is intended to improve. For this purpose, we consider the human functioning, in particular the conceptual model of International Classification of Functioning, Disability and Health (ICF). Considering that the ICF conceptual framework is accepted within the healthcare domain, the use of its concepts and terminologies to promote multidisciplinary approaches for AAL solutions development processes can help to overcome difficulties of communication between users, careers and technological developers. AAL solutions must consider in their development the needs of the person that will use AAL solutions. The development must be user-centred and usability questions cannot be forgotten. In addition, the acceptance of the AAL solutions is closely related to the quality of the systems, so it is necessary to appropriately assess these solutions.

Anesthesia Equipment E-Book
Anesthesia Equipment E-Book

Author: Jan Ehrenwerth

Publisher: Elsevier Health Sciences

Published: 2020-08-07

Total Pages: 659

ISBN-13: 0323775489

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Offering highly visual, easy-to-read coverage of the full range of anesthesia equipment in use today, this authoritative reference is your go-to text for objective, informed answers to ensure optimal patient safety. Anesthesia Equipment, 3rd Edition, provides detailed information on the intricate workings of each device or workstation, keeping you fully up to date and helping you meet both equipment and patient care challenges. - Remains unequalled in both depth and breadth of coverage, offering readable, concise guidance on all aspects of today's anesthesia machines and equipment. - Details the latest machines, vaporizers, ventilators, breathing systems, vigilance, ergonomics, and simulation. - Improves your understanding of the physical principles of equipment, the rationale for its use, delivery systems for inhalational anesthesia, systems monitoring, hazards and safety features, maintenance and quality assurance, special situations/equipment for non-routine adult anesthesia, and future directions for the field. - Includes ASA Practice Parameters for care, and helps you ensure patient safety with detailed advice on risk management and medicolegal implications of equipment use. - Highlights the text with hundreds of full-color line drawings and photographs, graphs, and charts. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices.

Clinical Engineering
Clinical Engineering

Author: Azzam Taktak

Publisher: Academic Press

Published: 2019-12-01

Total Pages: 554

ISBN-13: 0081026951

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Clinical Engineering: A Handbook for Clinical and Biomedical Engineers, Second Edition, helps professionals and students in clinical engineering successfully deploy medical technologies. The book provides a broad reference to the core elements of the subject, drawing from a range of experienced authors. In addition to engineering skills, clinical engineers must be able to work with both patients and a range of professional staff, including technicians, clinicians and equipment manufacturers. This book will not only help users keep up-to-date on the fast-moving scientific and medical research in the field, but also help them develop laboratory, design, workshop and management skills. The updated edition features the latest fundamentals of medical technology integration, patient safety, risk assessment and assistive technology. Provides engineers in core medical disciplines and related fields with the skills and knowledge to successfully collaborate on the development of medical devices, via approved procedures and standards Covers US and EU standards (FDA and MDD, respectively, plus related ISO requirements) Includes information that is backed up with real-life clinical examples, case studies, and separate tutorials for training and class use Completely updated to include new standards and regulations, as well as new case studies and illustrations