Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations PDF Download
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Author: Philip S. Cosgriff
Publisher: CRC Press
ISBN: 1040002358
Category : Science
Languages : en
Pages : 223
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Book Description
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: Philip S. Cosgriff
Publisher: CRC Press
ISBN: 1040002358
Category : Science
Languages : en
Pages : 223
Get Book Here
Book Description
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: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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Book Description
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.
Author: PHILIP S.. MEMMOTT COSGRIFF (MATTHEW.)
Publisher:
ISBN: 9781032293486
Category :
Languages : en
Pages : 0
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Book Description
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.
Author:
Publisher:
ISBN:
Category : Foreign trade regulation
Languages : en
Pages : 16
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Book Description
Author: Helen Delaney
Publisher: DIANE Publishing
ISBN: 1437900755
Category : Technology & Engineering
Languages : en
Pages : 36
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Book Description
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.
Author: U. S. Customs and Border Protection
Publisher:
ISBN: 9781304100061
Category : Education
Languages : en
Pages : 0
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Book Description
Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309142393
Category : Law
Languages : en
Pages : 348
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Book Description
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.
Author: Erik R. Ranschaert
Publisher: Springer
ISBN: 3319948784
Category : Medical
Languages : en
Pages : 369
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Book Description
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.
Author: World Intellectual Property Organization
Publisher: WIPO
ISBN: 9280523082
Category : Law
Languages : en
Pages : 259
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Book Description
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.
