Basem El-Haik Medical Device Design for Six Sigma

The first comprehensive guide to the integration of Design for Six Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness presents the complete body of knowledge for Design for Six Sigma (DFSS), as outlined by American Society for Quality, and details how to integrate appropriate design methodologies up front in the design process. DFSS helps companies shorten lead times, cut development and manufacturing costs, lower total life-cycle cost, and improve the quality of the medical devices. Comprehensive and complete with real-world examples, this guide: Integrates concept and design methods such as Pugh Controlled Convergence approach, QFD methodology, parameter optimization techniques like Design of Experiment (DOE), Taguchi Robust Design method, Failure Mode and Effects Analysis (FMEA), Design for X, Multi-Level Hierarchical Design methodology, and Response Surface methodology Covers contemporary and emerging design methods, including Axiomatic Design Principles, Theory of Inventive Problem Solving (TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process for each DFSS tool included Covers the structural, organizational, and technical deployment of DFSS within the medical device industry Includes a DFSS case study describing the development of a new device Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-on reference for medical device product development practitioners, product/service development engineers and architects, DFSS and Six Sigma trainees and trainers, middle management, engineering team leaders, quality engineers and quality consultants, and graduate students in biomedical engineering.

17245.3 RUR

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Basem El-Haik Simulation-based Lean Six-Sigma and Design for Six-Sigma

This is the first book to completely cover the whole body of knowledge of Six Sigma and Design for Six Sigma with Simulation Methods as outlined by the American Society for Quality. Both simulation and contemporary Six Sigma methods are explained in detail with practical examples that help understanding of the key features of the design methods. The systems approach to designing products and services as well as problem solving is integrated into the methods discussed.

14522.36 RUR

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Dale Tavris R. Medical Device Epidemiology and Surveillance

Medical devices are crucial in medical care today and device technology advances at a dizzying pace. Medical Device Epidemiology and Surveillance is the first book to provide an overview of medical device epidemiology and surveillance as well as perspectives from regulatory agencies, the medical device industry, the health insurance industry and academia. The book is edited by experts from the US Food and Drug Administration with contributions from experienced specialists working in this field in the US and around the world. It features chapters describing broad themes in medical device epidemiology and surveillance, as well as chapters that describe specific medical devices. Medical Device Epidemiology and Surveillance is an essential reference for epidemiologists, pharmacoepidemiologists, academics, graduate students, and everybody working in the medical device industry.

30860.02 RUR

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Basem El-Haik Axiomatic Quality

The first book to integrate axiomatic design and robust design for a comprehensive quality approach As the adoption of quality methods grows across various industries, its implementation is challenged by situations where statistical tools are inadequate, yet the earlier a proactive quality system is introduced into a given process, the greater the payback these methods will yield. Axiomatic Quality brings together two well-established theories, axiomatic design and robust design, to eliminate or reduce both conceptual and operational weaknesses. Providing a complete framework for immediate implementation, this book guides design teams in producing systems that operate at high-quality levels for each of their design requirements. And it shows the way towards achieving the Six-Sigma target–six times the standard deviation contained between the target and each side of the specification limits–for each requirement. This book develops an aggressive axiomatic quality approach that: * Provides the tools to reduce conceptual weaknesses of systems using a framework called the conceptual design for capability * Reduces operational weaknesses of systems in terms of quality losses and control costs * Uses mathematical relationships to bridge the gap between science-based engineering and quality methods Acclaro DFSS Light, a Java-based software package that implements axiomatic design processes, is available for download from a Wiley ftp site. Acclaro DFSS Light is a software product of Axiomatic Design Solutions, Inc. Laying out a comprehensive approach while working through each aspect of its implementation, Axiomatic Quality is an essential resource for managers, engineers, and other professionals who want to successfully deploy the most advanced methodology to tackle system weaknesses and improve quality.

14068.54 RUR

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Sandy Weinberg Cost-Contained Regulatory Compliance. For the Pharmaceutical, Biologics, and Medical Device Industries

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.

10524.17 RUR

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Claudio Becchetti Medical Instrument Design and Development

This book explains all of the stages involved in developing medical devices; from concept to medical approval including system engineering, bioinstrumentation design, signal processing, electronics, software and ICT with Cloud and e-Health development. Medical Instrument Design and Development offers a comprehensive theoretical background with extensive use of diagrams, graphics and tables (around 400 throughout the book). The book explains how the theory is translated into industrial medical products using a market-sold Electrocardiograph disclosed in its design by the Gamma Cardio Soft manufacturer. The sequence of the chapters reflects the product development lifecycle. Each chapter is focused on a specific University course and is divided into two sections: theory and implementation. The theory sections explain the main concepts and principles which remain valid across technological evolutions of medical instrumentation. The Implementation sections show how the theory is translated into a medical product. The Electrocardiograph (ECG or EKG) is used as an example as it is a suitable device to explore to fully understand medical instrumentation since it is sufficiently simple but encompasses all the main areas involved in developing medical electronic equipment. Key Features: Introduces a system-level approach to product design Covers topics such as bioinstrumentation, signal processing, information theory, electronics, software, firmware, telemedicine, e-Health and medical device certification Explains how to use theory to implement a market product (using ECG as an example) Examines the design and applications of main medical instruments Details the additional know-how required for product implementation: business context, system design, project management, intellectual property rights, product life cycle, etc. Includes an accompanying website with the design of the certified ECG product ( Discloses the details of a marketed ECG Product (from Gamma Cardio Soft) compliant with the ANSI standard AAMI EC 11 under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses (upper-level undergraduate and graduate students) and for engineers interested in medical instrumentation/device design with a comprehensive and interdisciplinary system perspective.

11373.58 RUR

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