Author: Publisher:
ISBN:
Category : Commerce
Languages : en
Pages : 220
Book Description
Export of Medical Devices
Author: Innovation and Protection
Author: I. Glenn CohenPublisher: Cambridge University Press
ISBN: 1108838634
Category : Law
Languages : en
Pages : 295
Book Description
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Export of Medical Devices
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
Import and Export Regulatory Requirements for Medical Devices
Author: Center for Devices and Radiological Health (U.S.). Office of Training and AssistancePublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 38
Book Description
Import/export
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 64
Book Description
Medical Device Regulations
Author: Michael ChengPublisher: 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.
Medical Devices
Author: Seeram RamakrishnaPublisher: Woodhead Publishing
ISBN: 0081002912
Category : Medical
Languages : en
Pages : 256
Book Description
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
Us Drug And Medical Devices Export-import Regulations Handbook
Author: USA (PRD) International Business PublicationsPublisher: International Business Publications USA
ISBN: 9780739729359
Category : Business & Economics
Languages : en
Pages : 404
Book Description
US Drug and Medical Devices Export-Import Regulations and contacts
Managing Medical Devices within a Regulatory Framework
Author: Beth Ann FiedlerPublisher: Elsevier
ISBN: 9780128041796
Category : Technology & Engineering
Languages : en
Pages : 0
Book Description
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.
Cybersecurity for Connected Medical Devices
Author: Arnab RayPublisher: Academic Press
ISBN: 0128182636
Category : Computers
Languages : en
Pages : 334
Book Description
The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program. Lays out clear guidelines for how to build a medical device cybersecurity program through the development of capabilities Discusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management System Provides a candidate method for system and software threat modelling Provides an overview of cybersecurity risk management for medical devices Presents technical cybersecurity controls for secure design of medical devices Provides an overview of cybersecurity verification and validation for medical devices Presents an approach to logically structure cybersecurity regulatory submissions
