Author: Michael Cheng Publisher: World Health Organization ISBN: 9241546182 Category : Medical Languages : en Pages : 54
Book Description
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: Great Britain Publisher: ISBN: 9780348223903 Category : Languages : en Pages :
Book Description
Enabling power: Medicines and Medical Devices Act 2021, ss. 50 (3), 51 (1). Bringing into operation various provisions of the 2021 Act on 26.05.21, in accord. with art. 2. Issued: 25.05.2021. Sifted: -. Made: 24.05.2021 @2.32 pm. Laid: -. Coming into force: 26.05.2021. Effect: None. Territorial extent & classification: E/W/S/NI. General
Author: Great Britain Publisher: ISBN: 9780105701040 Category : Languages : en Pages : 60
Book Description
Royal Assent, 11th February 2021. An Act to make provision about a Commissioner for Patient Safety in relation to human medicines and medical devices; confer power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices; make provision about the enforcement of regulations, and the protection of health and safety, in relation to medical devices. Explanatory Notes have been produced to assist in the understanding of this Act and are available separately. This Act extends to England and Wales, Scotland and Northern Ireland
Author: Publisher: Oxford University Press ISBN: 0198881940 Category : Political Science Languages : en Pages : 337
Book Description
Brexit and the Northern Ireland Constitution considers the intersection of two processes: the complex and constitutional process of the United Kingdom's withdrawal from the European Union - Brexit - and the steady yet fragile development of the Northern Ireland constitution deriving, primarily, from the Belfast 'Good Friday' Agreement of 1998. Interdisciplinary in approach, the analysis draws on legal and political theory to develop a novel framework for assessing the progressive impact of Brexit on the Northern Ireland constitution based on systematic definitions of both. This approach elucidates dynamics and implications not yet considered in the otherwise extensive debates about Brexit and its impacts on Northern Ireland. Based on detailed analysis of the Brexit process it is argued that its impact on the constitution of Northern Ireland has been profound. Fundamentally, Brexit changed the political and legal environment in which the Northern Ireland constitution had existed for over twenty years. Embracing 'constructive ambiguity' the 1998 Agreement recognises and accommodates the concerns of both unionists and nationalists in Northern Ireland; it did not therefore solve the constitutional conflict but rather allowed it to be managed differently through an innovative system of multileveled governance: within Northern Ireland (power-sharing devolution), on the island of Ireland (North-South cooperation), and between the islands of Great Britain and Ireland (East-West cooperation) all underpinned by a multifaceted principle of constitutional, popular, and cross-community consent. By forcing a paradigmatic shift in the way that the systems of government established by the 1998 Agreement operate, Brexit disrupted the 'constructively ambiguous' compromise that it represents. Completed two years after the legal implementation of UK withdrawal from the EU, Whitten concludes by considering the potential longer-term constitutional repercussions of Brexit both within and beyond Northern Ireland's (recently notorious) borders.
Author: G.R Higson Publisher: CRC Press ISBN: 9781420033984 Category : Medical Languages : en Pages : 300
Book Description
Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
Author: Dr Michael Powers KC Publisher: Bloomsbury Publishing ISBN: 1526521547 Category : Law Languages : en Pages : 1609
Book Description
"I would highly recommend this book...It is high quality, clear and comprehensive and will no doubt prove an invaluable source of reference. Five stars on all counts." Tim Kevan, co-editor, PIBULJ.COM This book remains the only text of its kind to cover both the medical and legal aspects of medical negligence. Written by a team of more than 60 experts, it continues to provide the most comprehensive and authoritative guidance on all aspects of clinical negligence claims, from bringing an action for damages to presenting expert evidence in court. It also includes detailed consideration of funding and cost implications. Those needing clear guidance to make the best possible preparations for an action will find all they need here. The new 6th edition has been fully revised and restructured, including new chapters on the future of clinical negligence litigation, cardiology, gynaecology, obstetrics, haematology , and also includes coverage and analysis of recent key cases such as: - Williams v Bermuda Hospitals [2016] UKPC 4 (causation) - R (on the application of Maughan) v HM Senior Coroner for Oxfordshire [2020] UKSC 46 (suicide in inquests) - Darnley v Croydon Health Authority [2018] UKSC 50 (duty of care owed by receptionist) - ABC v St George's Hosp [2020] EWHC 455 (Huntington's chorea confidentiality) - Swift v Carpenter [2020] EWCA Civ 1295 (future accommodation costs) - Whittington Hospital NHS Trust v XX [2020] UKSC 14 (damages for surrogacy) - Khan v Meadows [2021] UKSC 21 (scope of duty of care) - Nguyen v HM Assistant Coroner for Inner West London [2021] EWHC 3354 (sufficiency of inquiry) Easy-to-access structure The new edition maintains its easy-to-access, two-part structure. The first part, set out in 16 chapters, deals with legal aspects of medical malpractice, including complaints procedures, poor performance and medical professional governance, preparation of medical evidence, settlements and trial. There are also chapters on product liability, and coronial law. The final 27 chapters in the second part cover the risks associated with particular areas of specialist medical practice. This title is included in Bloomsbury Professional's Clinical Negligence online service.
Author: Philip S. Cosgriff Publisher: CRC Press ISBN: 1040002358 Category : Science Languages : en Pages : 223
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: Tamara Hervey Publisher: Bloomsbury Publishing ISBN: 1509951512 Category : Law Languages : en Pages : 279
Book Description
What does the UK's exit from the EU mean for health and the NHS? This book explains the legal and practical implications of Brexit on the NHS: its staffing; especially on the island of Ireland; medicines, medical devices and equipment; and biomedical research. It considers the UK's post-Brexit trade agreements and what they mean for health, and discusses the effects of the COVID-19 pandemic on post-Brexit health law. To put the legal analysis in context, the book draws on over 400 conversations the authors had with people in the north of England and Northern Ireland, interviews with over 40 health policy stakeholders, details of a film about their research made with ShoutOut UK, the authors' work with Parliaments and governments across the UK, and their collaborations with key actors like the NHS Confederation, the British Medical Association, and Cancer Research UK. The book shows that the language people use to talk about hoped-for legitimate post-Brexit health governance suggests a great deal of faith in law and legal process among 'ordinary people', but the opposite from 'insider elites'. Not What The Bus Promised puts the authors' knowledge and experiences centre frame, rather than claiming to express 'objective reality'. It will be of interest to any reader who cares about the NHS and wants to understand its present and future.
Author: Great Britain
Author: Michael Cheng
Author: Great Britain
Author: Great Britain
Author: Great Britain
Author: 
Author: G.R Higson
Author: Dr Michael Powers KC
Author: Philip S. Cosgriff
Author: Tamara Hervey