Writing In House Medical Device Software In Compliance With Eu Uk And Us Regulations

Author : Philip S. Cosgriff,Matthew J. Memmott
Publisher : CRC Press
Page : 223 pages
File Size : 43,5 Mb
Release : 2024-03-26
Category : Science
ISBN : 9781040002353

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Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations by Philip S. Cosgriff,Matthew J. Memmott Pdf

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.. MEMMOTT COSGRIFF (MATTHEW.),Matthew Memmott
Publisher : Unknown
Page : 0 pages
File Size : 45,5 Mb
Release : 2024-03-26
Category : Electronic
ISBN : 1032293489

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Writing In-House Medical Device Software in Compliance with Eu, Uk, and Us Regulations by PHILIP S.. MEMMOTT COSGRIFF (MATTHEW.),Matthew Memmott Pdf

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 : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 40,7 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188

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Medical Device Regulations by Michael Cheng,World Health Organization Pdf

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.

Author : Anonim
Publisher : Unknown
Page : 14 pages
File Size : 53,7 Mb
Release : 1997
Category : Foreign trade regulation
ISBN : PURD:32754068488281

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Marking of Country of Origin on U.S. Imports by Anonim Pdf

Author : World Health Organization
Publisher : World Health Organization
Page : 147 pages
File Size : 40,5 Mb
Release : 2010
Category : Medical
ISBN : 9789241564045

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Medical Devices by World Health Organization Pdf

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

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 318 pages
File Size : 40,5 Mb
Release : 2011-10-25
Category : Medical
ISBN : 9780309212458

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Medical Devices and the Public's Health by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

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 : Helena Legido-Quigley
Publisher : World Health Organization
Page : 242 pages
File Size : 48,6 Mb
Release : 2008
Category : Medical
ISBN : 9789289071932

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Assuring the Quality of Health Care in the European Union by Helena Legido-Quigley Pdf

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.

Author : U. S. Customs and Border Protection
Publisher : Unknown
Page : 0 pages
File Size : 53,6 Mb
Release : 2015-10-12
Category : Education
ISBN : 1304100065

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Importing Into the United States by U. S. Customs and Border Protection Pdf

Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.

Author : Adam Bohr,Kaveh Memarzadeh
Publisher : Academic Press
Page : 385 pages
File Size : 40,5 Mb
Release : 2020-06-21
Category : Computers
ISBN : 9780128184394

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Artificial Intelligence in Healthcare by Adam Bohr,Kaveh Memarzadeh Pdf

Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. Highlights different data techniques in healthcare data analysis, including machine learning and data mining Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks Includes applications and case studies across all areas of AI in healthcare data

Author : Charles Vincent,René Amalberti
Publisher : Springer
Page : 157 pages
File Size : 55,8 Mb
Release : 2016-01-13
Category : Medical
ISBN : 9783319255590

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Safer Healthcare by Charles Vincent,René Amalberti Pdf

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.

Author : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher : Unknown
Page : 32 pages
File Size : 50,5 Mb
Release : 1998
Category : Advertising
ISBN : UIUC:30112004816200

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Dietary Supplements by United States. Federal Trade Commission. Bureau of Consumer Protection Pdf

Author : Helen Delaney
Publisher : DIANE Publishing
Page : 36 pages
File Size : 49,5 Mb
Release : 2008-07
Category : Technology & Engineering
ISBN : 9781437900750

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Guide to EU Standards and Conformity Assessment by Helen Delaney Pdf

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 : Great Britain. National Audit Office
Publisher : Unknown
Page : 104 pages
File Size : 41,9 Mb
Release : 1999
Category : Political Science
ISBN : STANFORD:36105021834358

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The Management of Medical Equipment in NHS Acute Trusts in England by Great Britain. National Audit Office Pdf

On cover & title page:NHS Executive

Author : National Research Council,Division on Engineering and Physical Sciences,Committee on Applied and Theoretical Statistics,Policy and Global Affairs,Committee on Science, Technology, and Law,Committee on Identifying the Needs of the Forensic Sciences Community
Publisher : National Academies Press
Page : 348 pages
File Size : 52,6 Mb
Release : 2009-07-29
Category : Law
ISBN : 9780309142397

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Strengthening Forensic Science in the United States by National Research Council,Division on Engineering and Physical Sciences,Committee on Applied and Theoretical Statistics,Policy and Global Affairs,Committee on Science, Technology, and Law,Committee on Identifying the Needs of the Forensic Sciences Community Pdf

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 : United States. Federal Trade Commission
Publisher : Unknown
Page : 56 pages
File Size : 43,8 Mb
Release : 1998
Category : Buy national policy
ISBN : NYPL:33433067607980

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Complying with the Made in USA Standard by United States. Federal Trade Commission Pdf