Software As a Medical Device
Title | Software As a Medical Device PDF eBook |
Author | Gloria Hall |
Publisher | |
Pages | |
Release | 2021-04-23 |
Genre | |
ISBN | 9781947493612 |
Introduction to Medical Software
Title | Introduction to Medical Software PDF eBook |
Author | Xenophon Papademetris |
Publisher | Cambridge University Press |
Pages | 341 |
Release | 2022-05-05 |
Genre | Business & Economics |
ISBN | 1316514994 |
A concise and accessible overview of the design, implementation and management of medical software.
Medical Device Software Verification, Validation and Compliance
Title | Medical Device Software Verification, Validation and Compliance PDF eBook |
Author | David A. Vogel |
Publisher | Artech House |
Pages | 445 |
Release | 2011 |
Genre | Medical |
ISBN | 1596934239 |
HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."
Public Health Effectiveness of the FDA 510(k) Clearance Process
Title | Public Health Effectiveness of the FDA 510(k) Clearance Process PDF eBook |
Author | Institute of Medicine |
Publisher | National Academies Press |
Pages | 132 |
Release | 2011-06-10 |
Genre | Medical |
ISBN | 0309162068 |
The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.
Innovation and Protection
Title | Innovation and Protection PDF eBook |
Author | I. Glenn Cohen |
Publisher | Cambridge University Press |
Pages | 295 |
Release | 2022-04-07 |
Genre | Law |
ISBN | 1108838634 |
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Cybersecurity for Connected Medical Devices
Title | Cybersecurity for Connected Medical Devices PDF eBook |
Author | Arnab Ray |
Publisher | Academic Press |
Pages | 334 |
Release | 2021-11-09 |
Genre | Computers |
ISBN | 0128182636 |
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
Medical Devices and the Public's Health
Title | Medical Devices and the Public's Health PDF eBook |
Author | Institute of Medicine |
Publisher | National Academies Press |
Pages | 318 |
Release | 2011-10-25 |
Genre | Medical |
ISBN | 0309212456 |
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.