Principles Of Design Controls For Medical Device
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Principles Of Design Controls For Medical Device
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Author : David N. Muchemu
language : en
Publisher: CreateSpace
Release Date : 2012-03-01
Principles Of Design Controls For Medical Device written by David N. Muchemu and has been published by CreateSpace this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-03-01 with Self-Help categories.
A Refence book for Quality Engineers, Quality Managers, and Design Engineers in the medical device industry
Six Sigma For Medical Device Design
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Author : Jose Justiniano
language : en
Publisher: CRC Press
Release Date : 2004-11-15
Six Sigma For Medical Device Design written by Jose Justiniano and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-11-15 with Science categories.
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
Design Controls For The Medical Device Industry Second Edition
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Author : Marie B. Teixeira
language : en
Publisher: CRC Press
Release Date : 2013-11-12
Design Controls For The Medical Device Industry Second Edition written by Marie B. Teixeira and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-11-12 with Medical categories.
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 effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.
Medical Device Design For Six Sigma
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Author : Basem El-Haik
language : en
Publisher: John Wiley & Sons
Release Date : 2011-09-20
Medical Device Design For Six Sigma written by Basem El-Haik and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-20 with Medical categories.
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. Comprehensive and complete with real-world examples, thisguide: Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process foreach DFSS tool included Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry Includes a DFSS case study describing the development of a newdevice Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.
Design Controls For The Medical Device Industry
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Author : Marie B. Teixeira
language : en
Publisher: CRC Press
Release Date : 2002-09-20
Design Controls For The Medical Device Industry written by Marie B. Teixeira and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-09-20 with Medical categories.
This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.
Medical Device Regulations
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Author : Michael Cheng
language : en
Publisher: World Health Organization
Release Date : 2003-09-16
Medical Device Regulations written by Michael Cheng and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-09-16 with Medical categories.
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.
Humanizing Healthcare Human Factors For Medical Device Design
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Author : Russell J. Branaghan
language : en
Publisher: Springer Nature
Release Date : 2021-02-21
Humanizing Healthcare Human Factors For Medical Device Design written by Russell J. Branaghan and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-02-21 with Technology & Engineering categories.
This book introduces human factors engineering (HFE) principles, guidelines, and design methods for medical device design. It starts with an overview of physical, perceptual, and cognitive abilities and limitations, and their implications for design. This analysis produces a set of human factors principles that can be applied across many design challenges, which are then applied to guidelines for designing input controls, visual displays, auditory displays (alerts, alarms, warnings), and human-computer interaction. Specific challenges and solutions for various medical device domains, such as robotic surgery, laparoscopic surgery, artificial organs, wearables, continuous glucose monitors and insulin pumps, and reprocessing, are discussed. Human factors research and design methods are provided and integrated into a human factors design lifecycle, and a discussion of regulatory requirements and procedures is provided, including guidance on what human factors activities should be conducted when and how they should be documented. This hands-on professional reference is an essential introduction and resource for students and practitioners in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs. Teaches readers to design medical devices that are safer, more effective, and less error prone; Explains the role and responsibilities of regulatory agencies in medical device design; Introduces analysis and research methods such as UFMEA, task analysis, heuristic evaluation, and usability testing.
Design Controls For The Medical Device Industry Third Edition
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Author : Marie B. Teixeira
language : en
Publisher: CRC Press
Release Date : 2019-08-02
Design Controls For The Medical Device Industry Third Edition written by Marie B. Teixeira and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-02 with Medical categories.
This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements
Iso 13485 The Quality Management System For Medical Devices
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Author : Brendan Cooper
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2017-04-14
Iso 13485 The Quality Management System For Medical Devices written by Brendan Cooper and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-14 with categories.
This concise book is broadly divided into 3 manageable parts. The first part introduces the standard ISO 13485 and the basics of Quality management systems. Part two then examines the key area of Design controls and there application to medical devices. Finally, an overview of Quality Risk management is provided. In the first instance, providing safe and effective medical devices depends on a sound basis' of design. However, how we see and rate risks also impacts the safety of products produced. A holistic approach to medical device manufacturing ensures Quality from design conception to commercial manufacturing. Following the principles within this short book will put the reader on the right track. An ideal reference for industry or academics or those wishing to have a physical resource.
Class 1 Devices
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Author : Peter J Ogrodnik
language : en
Publisher: Academic Press
Release Date : 2014-11-24
Class 1 Devices written by Peter J Ogrodnik and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-11-24 with Technology & Engineering categories.
The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik’s Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS. These titles will assist anyone who is working in the medical devices industry or who is studying biomedical subject areas to design a successful medical device and avoid repeating past mistakes. Written by an experienced medical device engineer and entrepreneur, with real world experience of developing and commercializing medical products. Joins up theory and practice in an accessible style.