Writing In House Medical Device Software In Compliance With Eu Uk And Us Regulations
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Writing In House Medical Device Software In Compliance With Eu Uk And Us Regulations
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Author : Philip S. Cosgriff
language : en
Publisher: CRC Press
Release Date : 2024-03-26
Writing In House Medical Device Software In Compliance With Eu Uk And Us Regulations written by Philip S. Cosgriff and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-03-26 with Science categories.
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
Writing In House Medical Device Software In Compliance With Eu Uk And Us Regulations
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Author : PHILIP S.. MEMMOTT COSGRIFF (MATTHEW.)
language : en
Publisher:
Release Date : 2024-03-26
Writing In House Medical Device Software In Compliance With Eu Uk And Us Regulations written by PHILIP S.. MEMMOTT COSGRIFF (MATTHEW.) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-03-26 with categories.
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.
Medical Device Regulations
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Author : Michael Cheng
language : en
Publisher: World Health Organization
Release Date : 2003-09-16
Medical Device Regulations written by Michael Cheng and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-09-16 with Medical categories.
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.
Medical Devices And The Public S Health
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-10-25
Medical Devices And The Public S Health written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-25 with Medical categories.
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.
Medical Devices
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2010
Medical Devices written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Medical categories.
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
Bulletin Of The Atomic Scientists
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Author :
language : en
Publisher:
Release Date : 1955-04
Bulletin Of The Atomic Scientists written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1955-04 with categories.
The Bulletin of the Atomic Scientists is the premier public resource on scientific and technological developments that impact global security. Founded by Manhattan Project Scientists, the Bulletin's iconic "Doomsday Clock" stimulates solutions for a safer world.
The Management Of Medical Equipment In Nhs Acute Trusts In England
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Author : Great Britain. National Audit Office
language : en
Publisher:
Release Date : 1999
The Management Of Medical Equipment In Nhs Acute Trusts In England written by Great Britain. National Audit Office and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999 with Political Science categories.
On cover & title page:NHS Executive
Assuring The Quality Of Health Care In The European Union
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Author : Helena Legido-Quigley
language : en
Publisher: World Health Organization
Release Date : 2008
Assuring The Quality Of Health Care In The European Union written by Helena Legido-Quigley and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Medical categories.
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.
Best Practice Guidance For Healthcare Engineering
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Author : Great Britain
language : en
Publisher: The Stationery Office
Release Date : 2006-12-11
Best Practice Guidance For Healthcare Engineering written by Great Britain and has been published by The Stationery Office this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-12-11 with Medical categories.
This publication contains guidance on the standards and principles applicable to all health technical memoranda in this series in relation to the management of engineering and technical service provision in the NHS and other healthcare facilities. It seeks to ensure that everyone concerned with the management, design, procurement and use of the healthcare facility understands the requirements of the specialist, critical building and engineering technology involved, in order to provide effective and reliable systems and a safe and caring environment for patient care. It is divided into nine chapters and topics covered include: an overview of the Health technical memoranda (HTM) series; statutory and legislative requirements; appropriate professional and technical support; operational policies; emergency preparedness; staff training; design and access availability.
Guide To Eu Standards And Conformity Assessment
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Author : Helen Delaney
language : en
Publisher: DIANE Publishing
Release Date : 2008-07
Guide To Eu Standards And Conformity Assessment written by Helen Delaney and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-07 with Technology & Engineering categories.
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.