The Design and Manufacture of Medical Devices

• Author : J Paulo Davim
• Publisher : Elsevier
• Release : 16 October 2012

Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. The design

• Author : Peter J Ogrodnik
• Publisher : Academic Press
• Release : 17 December 2012

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

• Author : Richard C. Fries
• Publisher : CRC Press
• Release : 15 August 2019

First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

• Author : Basem El-Haik,Khalid S. Mekki
• Publisher : John Wiley & Sons
• Release : 20 September 2011

The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices.

• Author : Anonim
• Publisher : World Scientific
• Release : 13 January 2021

The era of the fourth industrial revolution has fundamentally transformed the manufacturing landscape. Products are getting increasingly complex and customers expect a higher level of customization and quality. Manufacturing in the Era of 4th Industrial Revolution explores three technologies that are the building blocks of the next-generation advanced manufacturing.The first technology covered in Volume 1 is Additive Manufacturing (AM). AM has emerged as a very popular manufacturing process. The most common form of AM is referred to as 'three-dimensional (3D)

• Author : Richard C. Fries
• Publisher : CRC Press
• Release : 21 November 2005

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects

• Author : Bojan Lalic,Danijela Gracanin,Nemanja Tasic,Nenad Simeunović
• Publisher : Springer Nature
• Release : 23 May 2022

This book proposes theoretically developed and practically tested solutions for manufacturing and business improvements achieved in the period between two conferences. It enables presentation of new knowledge and exchange of practical experience in industrial systems engineering and management. It brings together prominent researchers and practitioners from faculties, scientific institutes, and different enterprises or other organizations .This is the 18th edition of the conference. The Department of Industrial Engineering and Management at the Faculty of Technical Sciences in Novi Sad organizes

• Author : Bijan Elahi
• Publisher : Academic Press
• Release : 11 November 2021

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

• Author : Richard C. Fries
• Publisher : CRC Press
• Release : 06 September 2012

As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part

• Author : Syed Ali Ashter
• Publisher : William Andrew
• Release : 21 March 2022

Applications of Polymers and Plastics in Medical Devices: Design, Manufacture, and Performance is a comprehensive guide to plastic materials for medical devices, covering fundamentals, materials, applications and regulatory requirements. Sections cover the role of plastics in medical devices, socioeconomic factors, the classification of medical devices. The performance of, medical grades and suppliers of polymer materials, which are categorized by performance level are also explored, along with manufacturing processes for device components, including extrusion, casting, injection molding and assembly processes. The

• Author : Reinaldo Perez
• Publisher : Academic Press
• Release : 28 February 2002

Acknowledgments -- Introduction -- 1 Proper Design of Power Subsystems in Medical Electronics -- 2 Fundamentals of Magnetic Resonance Imaging -- 3 Particle Accelerator Design -- 4 Sensor Characteristics -- 5 Data Acquisition -- 6 Noise and Interference Issues in Analog Circuits -- 7 Hardware Approach to Digital Signal Processing -- 8 Optical Sensors -- Index.

• Author : Jose Justiniano,Venky Gopalaswamy
• Publisher : CRC Press
• Release : 15 November 2004

For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do

• Author : John J. Tobin,Gary Walsh
• Publisher : John Wiley & Sons
• Release : 24 August 2011

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/

• Author : Norman F. Estrin
• Publisher : CRC Press
• Release : 31 August 1990

Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach

• Author : Marie B. Teixeira,Marie Teixeira,Richard Bradley
• Publisher : CRC Press
• Release : 12 November 2013

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company's design control program evolves in accordance with current industry practice. The text assists in the development of an effectiv