Medical Device Regulatory Practices
DOWNLOAD
Download Medical Device Regulatory Practices PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Medical Device Regulatory Practices book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Medical Device Regulatory Practices
DOWNLOAD
Author : Val Theisz
language : en
Publisher: CRC Press
Release Date : 2015-08-03
Medical Device Regulatory Practices written by Val Theisz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-03 with Medical categories.
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
Medical Devices
DOWNLOAD
Author : Seeram Ramakrishna
language : en
Publisher: Woodhead Publishing
Release Date : 2015-08-18
Medical Devices written by Seeram Ramakrishna and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-18 with Medical categories.
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process
Handbook Of Medical Device Regulatory Affairs In Asia
DOWNLOAD
Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2013-03-27
Handbook Of Medical Device Regulatory Affairs In Asia written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-27 with Medical categories.
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.
Medical Device Regulations
DOWNLOAD
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 Device Regulations
DOWNLOAD
Author : Aakash Deep
language : en
Publisher: Academic Press
Release Date : 2022-01-13
Medical Device Regulations written by Aakash Deep and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-13 with Technology & Engineering categories.
Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products
Medical Device Regulation
DOWNLOAD
Author : Elijah Wreh
language : en
Publisher: Elsevier
Release Date : 2023-02-22
Medical Device Regulation written by Elijah Wreh and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-02-22 with Technology & Engineering categories.
Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. - Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification - Puts regulations in the context of contemporary design - Includes case studies and applications of regulations
Medical Devices
DOWNLOAD
Author : Christa Altenstetter
language : en
Publisher: Routledge
Release Date : 2017-09-08
Medical Devices written by Christa Altenstetter and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-08 with Medical categories.
Medical devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care, genetic testing, clinical trials, and experimental clinical investigations. Without medical devices, there is no clinical research or patient care. Without life-adjusting devices, there are no medical procedures or surgery. Without life-saving and life-maintaining devices, there is no improvement in well-being and quality of life. Without innovative medical devices and experimentation, there can be no medical progress or patient safety. Medical devices and medical technology are used to create or support many different products and medical-surgical procedures. This volume on the regulation of medical devices in the European Union, with a focus on France, tackles a topic of interdisciplinary interest and significance for policymakers in countries around the globe. The EU regulatory regime is one of three global regional regimes, and medical products manufactured in EU countries are sold worldwide. As countries confront an aging population on a global scale, with associated increases in chronic diseases, physical handicaps, and multi-morbidity, there will inevitably be an increase in the demand for health services and, concomitantly, the use of medical devices in medical and surgical procedures. This will be the case regardless of whether services are delivered in hospitals, doctors' offices, or at home. The associated risks of a particular device will be the same whatever the country of origin for the device, or where the need occurs. Revolutionary medical advances increase diagnostic capabilities, but they increase the potential of harm and risks to patients. Medical technologies and devices are used ethically most of the time; yet they have the potential for unethical use when scientific medicine is elevated over human life and death. Assumptions that are taken for granted can be dangerous to a patient's health. That is why our understanding of appropriate and effective regulation of medical devices is significant to all people on all continents.
Biomedical Devices
DOWNLOAD
Author : Tugrul Özel
language : en
Publisher: John Wiley & Sons
Release Date : 2016-09-13
Biomedical Devices written by Tugrul Özel and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09-13 with Science categories.
Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source
Encyclopedia Of Software Engineering Three Volume Set Print
DOWNLOAD
Author : Phillip A. Laplante
language : en
Publisher: CRC Press
Release Date : 2010-11-22
Encyclopedia Of Software Engineering Three Volume Set Print written by Phillip A. Laplante and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-11-22 with Computers categories.
Software engineering requires specialized knowledge of a broad spectrum of topics, including the construction of software and the platforms, applications, and environments in which the software operates as well as an understanding of the people who build and use the software. Offering an authoritative perspective, the two volumes of the Encyclopedia of Software Engineering cover the entire multidisciplinary scope of this important field. More than 200 expert contributors and reviewers from industry and academia across 21 countries provide easy-to-read entries that cover software requirements, design, construction, testing, maintenance, configuration management, quality control, and software engineering management tools and methods. Editor Phillip A. Laplante uses the most universally recognized definition of the areas of relevance to software engineering, the Software Engineering Body of Knowledge (SWEBOK®), as a template for organizing the material. Also available in an electronic format, this encyclopedia supplies software engineering students, IT professionals, researchers, managers, and scholars with unrivaled coverage of the topics that encompass this ever-changing field. Also Available Online This Taylor & Francis encyclopedia is also available through online subscription, offering a variety of extra benefits for researchers, students, and librarians, including: Citation tracking and alerts Active reference linking Saved searches and marked lists HTML and PDF format options Contact Taylor and Francis for more information or to inquire about subscription options and print/online combination packages. US: (Tel) 1.888.318.2367; (E-mail) [email protected] International: (Tel) +44 (0) 20 7017 6062; (E-mail) [email protected]
A Critical Review Of Australia S Regulatory Oversight For New Generation Personalised Medical Devices
DOWNLOAD
Author : Aman Grewal
language : en
Publisher: Ethics International Press
Release Date : 2024-09-16
A Critical Review Of Australia S Regulatory Oversight For New Generation Personalised Medical Devices written by Aman Grewal and has been published by Ethics International Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-09-16 with Medical categories.
Australia's medical device regulator Therapeutic Goods Administration (TGA) generally uses the term personalised medical device to describe medical devices made available to address specific individual requirements. 2019 Regulatory amendments including new definitions for personalised medical devices involved the subdivision of personalised medical devices into three categories of custom-made medical devices, patient-matched medical devices and adaptable medical devices, and the adaptation of the International Medical Device Regulatory Forum's (IMDRF’s) definitions for personalised medical devices. This book highlights inadequacies and oversights in the current regulatory regime, and explores possible solutions to address them. The study focuses on the regulatory control of personalised medical devices in Australia, but elements of the proposed regime are also compared with similar elements within the United States and South Korean medical device regulatory frameworks. The book also explores some technically complex medical and legal principles and issues that arise and interact with each other in the application of personalised medical devices. It concludes with specific observations and recommendations aimed at improving the current Australian regulatory framework for new-generation personalised medical devices. This study also examines the benefits and drawbacks of the IMDRF-led regulatory reforms in various international jurisdictions. The IMDRF is spearheading medical device international regulatory alignment; therefore, the scope and significance of the information discussed is important in international jurisdictions. This detailed study is a key reference work for academic researchers, medical device manufacturers and sponsors, and legal and regulatory experts.