Application Of Risk Management For It Networks Incorporating Medical Devices Part 1 Roles Responsibilities And Activities
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Risk Management For The Medical Device Industry
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Author : Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra
language : en
Publisher: Notion Press
Release Date : 2023-07-25
Risk Management For The Medical Device Industry written by Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra and has been published by Notion Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-07-25 with Medical categories.
"Risk Management for the Medical Device Industry: A Guide based on ISO 14971" is an essential resource for professionals in the fast-paced medical device industry. Authored by Dr. Akash Sharma, Ms. Vriti Gamta, and Mr. Gaurav Luthra, experts in regulatory affairs and quality management systems, this practical guide offers comprehensive insights into risk management and compliance. Covering the entire risk management lifecycle, it includes case studies, best practices, and practical examples, along with discussions on integrating risk management with quality management systems and emerging technologies. Equip yourself with the knowledge and tools to ensure safety and effectiveness in the global market.
Medical Device Regulatory Practices
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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
Healthcare Technology Management A Systematic Approach
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Author : Francis Hegarty
language : en
Publisher: CRC Press
Release Date : 2017-01-06
Healthcare Technology Management A Systematic Approach written by Francis Hegarty and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-01-06 with Business & Economics categories.
Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and other care providers, as well as financial stakeholders. The authors propose a management model based on interlinked strategic and operational quality cycles which, when fully realized, delivers a comprehensive and transparent methodology for implementing a HTM programme throughout a healthcare organization. The approach proposes that HTM extends beyond managing the technology in isolation to include advancing patient care through supporting the application of the technology. The book shows how to cost effectively manage medical equipment through its full life cycle, from acquisition through operational use to disposal, and to advance care, adding value to the medical equipment assets for the benefit of patients and stakeholders. This book will be of interest to practicing clinical engineers and to students and lecturers, and includes self-directed learning questions and case studies. Clinicians, Chief Executive Officers, Directors of Finance and other hospital managers with responsibility for the governance of medical equipment will also find this book of interest and value. For more information about the book, please visit the website.
Managing Medical Devices Within A Regulatory Framework
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Author : Beth Ann Fiedler
language : en
Publisher: Elsevier
Release Date : 2016-09-10
Managing Medical Devices Within A Regulatory Framework written by Beth Ann Fiedler and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09-10 with Law categories.
Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. - Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices - Provides operational and clinical practice recommendations in regard to regulatory changes for risk management - Discusses best practices for equipment procurement and maintenance - Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices
Internet Of Things Technology In Healthcare Fundamentals Principles And Cyber Security Issues
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Author : V.Anand
language : en
Publisher: Anand Vemula
Release Date :
Internet Of Things Technology In Healthcare Fundamentals Principles And Cyber Security Issues written by V.Anand and has been published by Anand Vemula this book supported file pdf, txt, epub, kindle and other format this book has been release on with Computers categories.
This book aims at providing details of security foundation and implementation for connected healthcare. The key tenets of the cyber security – Inventory, of hardware and software, prioritization of the critical data and applications, monitoring, advanced defense with secure SDLC and testing. The various components including, risk mitigation strategies and the long-term roadmap for the implementation of the security within the healthcare space. It also gives a deep dive on the various regulations pertaining the healthcare devices and other components of the healthcare value chain. The book also focuses on the incident reporting, the total product lifecycle framework, and how innovation can help achieve the maturity through some of the tools stack.
Federal Register
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Author :
language : en
Publisher:
Release Date : 2013-08
Federal Register written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-08 with Delegated legislation categories.
World Congress On Medical Physics And Biomedical Engineering May 26 31 2012 Beijing China
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Author : Mian Long
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-02-11
World Congress On Medical Physics And Biomedical Engineering May 26 31 2012 Beijing China written by Mian Long and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-11 with Technology & Engineering categories.
The congress’s unique structure represents the two dimensions of technology and medicine: 13 themes on science and medical technologies intersect with five challenging main topics of medicine to create a maximum of synergy and integration of aspects on research, development and application. Each of the congress themes was chaired by two leading experts. The themes address specific topics of medicine and technology that provide multiple and excellent opportunities for exchanges.
Foundations Of Health Information Engineering And Systems
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Author : Jeremy Gibbons
language : en
Publisher: Springer
Release Date : 2014-01-09
Foundations Of Health Information Engineering And Systems written by Jeremy Gibbons and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-01-09 with Computers categories.
This book constitutes the thoroughly refereed post-conference proceedings of the Third International Symposium on Foundations of Health Information Engineering and Systems, FHIES 2013, held in Macau, China, in August 2013. The 19 revised full papers presented together with 1 invited talk in this volume were carefully reviewed and selected from 22 submissions. The papers are organized in following subjects: panel position statements, pathways, generation and certification, interoperability, patient safety, device safety, formal methods and HIV/AIDS and privacy.
The Biomedical Quality Auditor Handbook Third Edition
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Author : Heather Crawford
language : en
Publisher: Quality Press
Release Date : 2017-09-08
The Biomedical Quality Auditor Handbook Third Edition written by Heather Crawford and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-08 with Business & Economics categories.
The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQs Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.
Clinical Engineering
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Author : Azzam Taktak
language : en
Publisher: Academic Press
Release Date : 2019-12-01
Clinical Engineering written by Azzam Taktak and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-12-01 with Computers categories.
Clinical Engineering: A Handbook for Clinical and Biomedical Engineers, Second Edition, helps professionals and students in clinical engineering successfully deploy medical technologies. The book provides a broad reference to the core elements of the subject, drawing from a range of experienced authors. In addition to engineering skills, clinical engineers must be able to work with both patients and a range of professional staff, including technicians, clinicians and equipment manufacturers. This book will not only help users keep up-to-date on the fast-moving scientific and medical research in the field, but also help them develop laboratory, design, workshop and management skills. The updated edition features the latest fundamentals of medical technology integration, patient safety, risk assessment and assistive technology. - Provides engineers in core medical disciplines and related fields with the skills and knowledge to successfully collaborate on the development of medical devices, via approved procedures and standards - Covers US and EU standards (FDA and MDD, respectively, plus related ISO requirements) - Includes information that is backed up with real-life clinical examples, case studies, and separate tutorials for training and class use - Completely updated to include new standards and regulations, as well as new case studies and illustrations