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
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 . This book was released on 2024-03 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 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
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Marking of Country of Origin on U S Imports written by and published by . This book was released on 1997 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Importing Into the United States written by U. S. Customs and Border Protection and published by . This book was released on 2015-10-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
Download or read book The Management of Medical Equipment in NHS Acute Trusts in England written by Great Britain. National Audit Office and published by . This book was released on 1999 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt: On cover & title page:NHS Executive
Download or read book Assuring the Quality of Health Care in the European Union written by Helena Legido-Quigley and published by World Health Organization. This book was released on 2008 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Download or read book Guide to EU Standards and Conformity Assessment written by Helen Delaney and published by DIANE Publishing. This book was released on 2008-07 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: An easy-to-use introductory guide for industry and gov¿t. officials on the principles and concepts behind the European Union¿s (EU) ¿New Approach¿ laws and directives. Will help bus. and gov¿t. officials understand the new laws, the EU¿s standardization process, and the relationships between the European Comm. and the European standardization bodies in the EU. Also provides info. on the EU¿s approach to conformity assessment and requirements for obtaining the CE mark to gain access to the European Market. Offers explanations of such requirements as: notified bodies, conformity assessment modules, supplier¿s declaration of conformity, tech. construction files, user manuals, authorized rep., and product liability in the EU. Charts and tables.
Download or read book Final Report etc written by Committee appointed at a General Meeting of the Wine Trade (LONDON) and published by . This book was released on 1843 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Download or read book Strengthening Forensic Science in the United States written by National Research Council and published by National Academies Press. This book was released on 2009-07-29 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators.
Download or read book Complying with the Made in USA Standard written by United States. Federal Trade Commission and published by . This book was released on 1998 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Download or read book Safer Healthcare written by Charles Vincent and published by Springer. This book was released on 2016-01-13 with total page 157 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authors of this book set out a system of safety strategies and interventions for managing patient safety on a day-to-day basis and improving safety over the long term. These strategies are applicable at all levels of the healthcare system from the frontline to the regulation and governance of the system. There have been many advances in patient safety, but we now need a new and broader vision that encompasses care throughout the patient’s journey. The authors argue that we need to see safety through the patient’s eyes, to consider how safety is managed in different contexts and to develop a wider strategic and practical vision in which patient safety is recast as the management of risk over time. Most safety improvement strategies aim to improve reliability and move closer toward optimal care. However, healthcare will always be under pressure and we also require ways of managing safety when conditions are difficult. We need to make more use of strategies concerned with detecting, controlling, managing and responding to risk. Strategies for managing safety in highly standardised and controlled environments are necessarily different from those in which clinicians constantly have to adapt and respond to changing circumstances. This work is supported by the Health Foundation. The Health Foundation is an independent charity committed to bringing about better health and health care for people in the UK. The charity’s aim is a healthier population in the UK, supported by high quality health care that can be equitably accessed. The Foundation carries out policy analysis and makes grants to front-line teams to try ideas in practice and supports research into what works to make people’s lives healthier and improve the health care system, with a particular emphasis on how to make successful change happen. A key part of the work is to make links between the knowledge of those working to deliver health and health care with research evidence and analysis. The aspiration is to create a virtuous circle, using what works on the ground to inform effective policymaking and vice versa. Good health and health care are vital for a flourishing society. Through sharing what is known, collaboration and building people’s skills and knowledge, the Foundation aims to make a difference and contribute to a healthier population.
Download or read book Artificial Intelligence in Medical Imaging written by Erik R. Ranschaert and published by Springer. This book was released on 2019-01-29 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a thorough overview of the ongoing evolution in the application of artificial intelligence (AI) within healthcare and radiology, enabling readers to gain a deeper insight into the technological background of AI and the impacts of new and emerging technologies on medical imaging. After an introduction on game changers in radiology, such as deep learning technology, the technological evolution of AI in computing science and medical image computing is described, with explanation of basic principles and the types and subtypes of AI. Subsequent sections address the use of imaging biomarkers, the development and validation of AI applications, and various aspects and issues relating to the growing role of big data in radiology. Diverse real-life clinical applications of AI are then outlined for different body parts, demonstrating their ability to add value to daily radiology practices. The concluding section focuses on the impact of AI on radiology and the implications for radiologists, for example with respect to training. Written by radiologists and IT professionals, the book will be of high value for radiologists, medical/clinical physicists, IT specialists, and imaging informatics professionals.
