Download or read book Improving Patient Safety Through Medical Device Interoperability and High Confidence Software Proceedings High Confidence Medical Devices Software and Systems Medical Device Plug and Play Interoperability 2007 Cambridge MA written by Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability and published by . This book was released on 2007 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book High confidence Medical Devices written by and published by . This book was released on 2009 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The authors of this report point to fundamental scientific and technical challenges posed by the rapidly expanding digital environment in medicine and health care and they identify critical research advances that are needed to enable the design and manufacture of new generations of increasingly complex, interconnected, and interoperating medical device cyber-physical systems that will offer innovative new capabilities and function far more safely, securely, and reliably than today's medical devices.
Download or read book High confidence Medical Devices written by and published by . This book was released on 2009 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Improving Patient Safety Through Medical Device Interoperability and High Confidence Software Proceedings written by and published by . This book was released on 2007 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book High Confidence Medical Devices Software and Systems and Medical Device Plug and Play Interoperability 2007 HCMDSS MDPnP Joint Workshop on written by and published by . This book was released on 2010 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book High confidence Medical Devices written by and published by . This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authors of this report point to fundamental scientific and technical challenges posed by the rapidly expanding digital environment in medicine and health care and they identify critical research advances that are needed to enable the design and manufacture of new generations of increasingly complex, interconnected, and interoperating medical device cyber-physical systems that will offer innovative new capabilities and function far more safely, securely, and reliably than today's medical devices.
Download or read book Cybersecurity for Connected Medical Devices written by Arnab Ray and published by Academic Press. This book was released on 2021-11-09 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program. Lays out clear guidelines for how to build a medical device cybersecurity program through the development of capabilities Discusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management System Provides a candidate method for system and software threat modelling Provides an overview of cybersecurity risk management for medical devices Presents technical cybersecurity controls for secure design of medical devices Provides an overview of cybersecurity verification and validation for medical devices Presents an approach to logically structure cybersecurity regulatory submissions
Download or read book Statistical Procedures for the Medical Device Industry written by Wayne A. Taylor and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book 2007 Joint Workshop on High Confidence Medical Devices Software and Systems and Medical Device Plug and Play Interoperability written by and published by . This book was released on 2007 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Networking and Information Technology Research and Development written by National Science and Technology Council (U.S.). Subcommittee on Networking and Information Technology Research and Development and published by . This book was released on 2005 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Networking and Information Technology Research and Development Program NITRD written by Patricia Moloney Figliola and published by DIANE Publishing. This book was released on 2010-08 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contents: (1) Overview, Structure and Funding of NITRD:: Amer. Recovery and Reinvest. Act of 2009; Amer. Competitiveness Initiative; NCO, PITAC, and Related Reports and Activities: National Cyber Leap Year Summit; High-Confidence Medical Devices: Cyber-Physical Systems for 21st Cent. Health Care; Digital Data for Science and Society; Fed. Plan for Advanced Networking R&D; Info. Tech. R&D in a Competitive World; Fed. Plan for Cyber Security and Info. Assurance R&D; NSA Superconducting Tech. Assessment; Computational Science; Cyber Security; NITRD Enabling and Governing Legislation: High-Performance Computing Act of 1991; Next Generation Internet Research Act of 1998; (2) Fed. Tech. Funding. Illus.
Download or read book Networking and Information Technology Research and Development Program written by Sally E. Howe and published by DIANE Publishing. This book was released on 2008-08 with total page 37 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes R&D activities in advanced networking, software, high-end computing and computational science, cyber security, and other leading-edge information technologies (IT) funded by the 13 Fed. Agencies in the Networking and IT R&D (NITRD) Program. Capabilities and tools generated through NITRD investments accelerate advances across the spectrum of science, engineering, and technology fields, supporting key national security and scientific missions of the Fed. Gov¿t. and enhancing the Nation's economic competitiveness. The Pres.¿s FY2009 Budget provides a 6% increase for the NITRD Program overall, reflecting the vital contributions of networking and IT to sustaining U.S. leadership in science and technology.
Download or read book Proactive Supplier Management in the Medical Device Industry written by James B. Shore and published by Quality Press. This book was released on 2016-05-06 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business aspect. The intent of this book is to show readers a process of effectively selecting, evaluating, and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, consultants, and contractors in a state of compliance. These processes can be applied to all suppliers, consultants, and contractors. In writing this book, the authors made sure that readers could immediately apply its content. They provide best practices based on a combined 50+ years of quality and engineering experience, having worked with some of the best medical device companies and contract manufacturers in the world. Four icons use throughout the book help readers navigate and understand the content. The FDA and toolbox icons assist in determining whether its a requirement or a tool to help achieve compliance. The Lessons from the Road icon indicates real-life stories and what the authors have learned throughout their careers. Lastly, the check mark icon is used to highlight key thoughts, what they feel are unique takeaways or deserve a special focus.
Download or read book Y2K and Medical Devices written by United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1999 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Public Health Effectiveness of the FDA 510 k Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2011-06-10 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.
Download or read book The Medical Device Industry written by John Burton and published by Cambridge Scholars Publishing. This book was released on 2009-03-26 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector. The increase in the complexity of medical device software has introduced new challenges with respect to making medical devices and their associated software safe. Risk management has emerged as key in addressing these challenges. Existing literature on risk management for medical devices has been slow to adequately account for the complex nature of software in modern medical devices. Conversely, excellent progress has been made in the broader Software Engineering community with the production of holistic software risk based models such as the Capability Maturity Model Integration (CMMI®) and SPICE™. However, these models do not account for medical device specific requirements. This book examines the possibility of a unified approach whilst investigating the relevance of the CMMI® SPI model to the medical device regulatory requirements.
Download or read book Software for Dependable Systems written by National Research Council and published by National Academies Press. This book was released on 2007-08-14 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of Software for Dependable Systems is a set of fundamental principles that underlie software system dependability and that suggest a different approach to the development and assessment of dependable software. Unfortunately, it is difficult to assess the dependability of software. The field of software engineering suffers from a pervasive lack of evidence about the incidence and severity of software failures; about the dependability of existing software systems; about the efficacy of existing and proposed development methods; about the benefits of certification schemes; and so on. There are many anecdotal reports, which-although often useful for indicating areas of concern or highlighting promising avenues of research-do little to establish a sound and complete basis for making policy decisions regarding dependability. The committee regards claims of extraordinary dependability that are sometimes made on this basis for the most critical of systems as unsubstantiated, and perhaps irresponsible. This difficulty regarding the lack of evidence for system dependability leads to two conclusions: (1) that better evidence is needed, so that approaches aimed at improving the dependability of software can be objectively assessed, and (2) that, for now, the pursuit of dependability in software systems should focus on the construction and evaluation of evidence. The committee also recognized the importance of adopting the practices that are already known and used by the best developers; this report gives a sample of such practices. Some of these (such as systematic configuration management and automated regression testing) are relatively easy to adopt; others (such as constructing hazard analyses and threat models, exploiting formal notations when appropriate, and applying static analysis to code) will require new training for many developers. However valuable, though, these practices are in themselves no silver bullet, and new techniques and methods will be required in order to build future software systems to the level of dependability that will be required.
