Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

Produk Detail:

  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Pages : 534 pages
  • ISBN : 0323918239
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKSafety Risk Management for Medical Devices

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release : 11 November 2021
GET THIS BOOKSafety Risk Management for Medical Devices

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to

Medical Devices

Medical Devices
  • Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
  • Publisher : Woodhead Publishing
  • Release : 18 August 2015
GET THIS BOOKMedical Devices

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

Implantable Electronic Medical Devices

Implantable Electronic Medical Devices
  • Author : Dennis Fitzpatrick
  • Publisher : Elsevier
  • Release : 05 November 2014
GET THIS BOOKImplantable Electronic Medical Devices

Implantable Electronic Medical Devices provides a thorough review of the application of implantable devices, illustrating the techniques currently being used together with overviews of the latest commercially available medical devices. This book provides an overview of the design of medical devices and is a reference on existing medical devices. The book groups devices with similar functionality into distinct chapters, looking at the latest design ideas and techniques in each area, including retinal implants, glucose biosensors, cochlear implants, pacemakers, electrical stimulation

Plastics in Medical Devices

Plastics in Medical Devices
  • Author : Vinny R. Sastri
  • Publisher : Elsevier
  • Release : 05 March 2010
GET THIS BOOKPlastics in Medical Devices

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the

Energy Efficiency of Medical Devices and Healthcare Applications

Energy Efficiency of Medical Devices and Healthcare Applications
  • Author : Amr Mohamed
  • Publisher : Academic Press
  • Release : 15 February 2020
GET THIS BOOKEnergy Efficiency of Medical Devices and Healthcare Applications

Energy Efficiency of Medical Devices and Healthcare Facilities provides comprehensive coverage of cutting-edge, interdisciplinary research, and commercial solutions in this field. The authors discuss energy-related challenges, such as energy-efficient design, including renewable energy, of different medical devices from a hardware and mechanical perspectives, as well as energy management solutions and techniques in healthcare networks and facilities. They also discuss energy-related trade-offs to maximize the medical devices availability, especially battery-operated ones, while providing immediate response and low latency communication in emergency

Nanoparticles in Analytical and Medical Devices

Nanoparticles in Analytical and Medical Devices
  • Author : Fang Gang
  • Publisher : Elsevier
  • Release : 01 September 2020
GET THIS BOOKNanoparticles in Analytical and Medical Devices

Nanoparticles in Analytical and Medical Devices presents the latest information on the use of nanoparticles for a diverse range of analytical and medical applications. Covers basic principles, proper use of nanoparticles in analytical and medical applications, and recent progress in the field. This comprehensive reference helps readers grasp the full potential of nanoparticles in their analytical research or medical practice. Chapters on cutting-edge topics bring readers up to date on the latest research and usage of nanoparticles, and a chapter

Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework
  • Author : Beth Ann Fiedler
  • Publisher : Elsevier
  • Release : 10 September 2016
GET THIS BOOKManaging Medical Devices within a Regulatory Framework

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,

Medical Device Technologies

Medical Device Technologies
  • Author : Gail D. Baura
  • Publisher : Academic Press
  • Release : 17 May 2022
GET THIS BOOKMedical Device Technologies

The goal of this textbook is to provide undergraduate engineering students with an introduction to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining 8 chapters are medical device laboratory experiment chapters. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function

Medical Device Design

Medical Device Design
  • Author : Peter J Ogrodnik
  • Publisher : Academic Press
  • Release : 17 December 2012
GET THIS BOOKMedical Device Design

This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers

Cybersecurity for Connected Medical Devices

Cybersecurity for Connected Medical Devices
  • Author : Arnab Ray
  • Publisher : Academic Press
  • Release : 09 November 2021
GET THIS BOOKCybersecurity for Connected Medical Devices

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).

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
  • Author : Jean-Pierre Boutrand
  • Publisher : Woodhead Publishing
  • Release : 21 November 2019
GET THIS BOOKBiocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in

Wearable and Implantable Medical Devices

Wearable and Implantable Medical Devices
  • Author : Nilanjan Dey,Amira S. Ashour,Simon James Fong,Chintan Bhatt
  • Publisher : Academic Press
  • Release : 06 September 2019
GET THIS BOOKWearable and Implantable Medical Devices

Wearable and Implantable Medical Devices: Applications and Challenges, Fourth Edition highlights the new aspects of wearable and implanted sensors technology in the healthcare sector and monitoring systems. The book's contributions include several interdisciplinary domains, such as wearable sensors, implanted sensors devices, Internet-of-Things (IoT), security, real-time medical healthcare monitoring, WIBSN design and data management, encryption, and decision-support systems. Contributions emphasize several topics, including real-world applications and the design and implementation of wearable devices. This book demonstrates that this new field has

Biofilms and Implantable Medical Devices

Biofilms and Implantable Medical Devices
  • Author : Ying Deng,Wei Lv
  • Publisher : Woodhead Publishing
  • Release : 24 October 2016
GET THIS BOOKBiofilms and Implantable Medical Devices

Biofilms and Implantable Medical Devices: Infection and Control explores the increasing use of permanent and semi-permanent implants and indwelling medical devices. As an understanding of the growth and impact of biofilm formation on these medical devices and biomaterials is vital for protecting the health of the human host, this book provides readers with a comprehensive treatise on biofilms and their relationship with medical devices, also reporting on infections and associated strategies for prevention. Provides useful information on the fundamentals of

Bioelectronics and Medical Devices

Bioelectronics and Medical Devices
  • Author : Dr. Kunal Pal,Heinz-Bernhard Kraatz,Anwesha Khasnobish,Sandip Bag,Indranil Banerjee,Usha Kuruganti
  • Publisher : Woodhead Publishing
  • Release : 15 June 2019
GET THIS BOOKBioelectronics and Medical Devices

Bioelectronics and Medical Devices: From Materials to Devices-Fabrication, Applications and Reliability reviews the latest research on electronic devices used in the healthcare sector, from materials, to applications, including biosensors, rehabilitation devices, drug delivery devices, and devices based on wireless technology. This information is presented from the unique interdisciplinary perspective of the editors and contributors, all with materials science, biomedical engineering, physics, and chemistry backgrounds. Each applicable chapter includes a discussion of these devices, from materials and fabrication, to reliability and

Sterilization of Medical Devices

Sterilization of Medical Devices
  • Author : Anne Booth
  • Publisher : Routledge
  • Release : 12 December 2018
GET THIS BOOKSterilization of Medical Devices

This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and