Industrial Metrology For Medical Products And Devices
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Industrial Metrology For Medical Products And Devices
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Author : Robert Roithmeier
language : en
Publisher: Carl Zeiss AG
Release Date :
Industrial Metrology For Medical Products And Devices written by Robert Roithmeier and has been published by Carl Zeiss AG this book supported file pdf, txt, epub, kindle and other format this book has been release on with Technology & Engineering categories.
Medical progress is associated with innovative product developments in medical technology, e.g. for different implants and instruments. The developments are also characterized by increasing miniaturization and precision. Hence the demands on the geometric and surface characteristics of the usually complex form elements are growing. Consequently, the need for highly-accurate dimensional inspection for the verification of these characteristics is rapidly increasing. ZEISS successfully and reliably faces these challenges. Being a leading manufacturer of medical technology as well as of measurement and inspection technology, the company ZEISS has a high level of know-how in the industrial production of medical devices and products. This book presents the metrological solutions for the medical technology and explains their application. The required measuring machines and the task-based sensors are addressed to the same extent as the challenges regarding automated 100 % checks. Methods for checking the reliability of measuring results and evaluating the inspection process quality are presented and the required procedures are described in detail. The extended regulations for medical devices and products, e.g. by FDA and MDR, place high demands on the measurement technology used and on the electronic documentation of measurement results. This is addressed in detail at the end of the book; in the appendix, easy-to-use checklists for the regulations according to 21 CFR Part 11 are provided.
Industrial Metrology For Medical Products And Devices
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Author : Robert Dr. Roithmeier
language : en
Publisher:
Release Date : 2020
Industrial Metrology For Medical Products And Devices written by Robert Dr. Roithmeier and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with categories.
Medical Devices Measurements Quality Assurance And Standards
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Author : Cesar Augusto Caceres
language : en
Publisher: ASTM International
Release Date : 1983
Medical Devices Measurements Quality Assurance And Standards written by Cesar Augusto Caceres and has been published by ASTM International this book supported file pdf, txt, epub, kindle and other format this book has been release on 1983 with Medical instruments and apparatus categories.
Inspection Of Medical Devices
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Author : Almir Badnjević
language : en
Publisher: Springer
Release Date : 2023-11-27
Inspection Of Medical Devices written by Almir Badnjević and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-27 with Technology & Engineering categories.
This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!
Quality Control Applications In The Pharmaceutical And Medical Device Manufacturing Industry
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Author : Carrillo-Cedillo, Eugenia Gabriela
language : en
Publisher: IGI Global
Release Date : 2022-03-18
Quality Control Applications In The Pharmaceutical And Medical Device Manufacturing Industry written by Carrillo-Cedillo, Eugenia Gabriela and has been published by IGI Global this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-03-18 with Technology & Engineering categories.
Quality control in pharmaceutical products and medical devices is vital for users as failing to comply with national and international regulations can lead to accidents that could easily be avoided. For this reason, manufacturing a quality medical product will support patient safety. Microbiologists working in both the pharmaceutical and medical device industries face considerable challenges in keeping abreast of the myriad microbiological references available to them and the continuously evolving regulatory requirements. Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry presents the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards to not cause problems to the health of patients. It reinforces and updates the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices. Covering topics such as pharmaceutical nano systems, machine learning, and software validation, this book is an essential resource for managers, engineers, supervisors, pharmacists, chemists, academicians, and researchers.
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 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.
Metrology In Industry
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Author : French College of Metrology
language : en
Publisher: John Wiley & Sons
Release Date : 2013-03-01
Metrology In Industry written by French College of Metrology 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 2013-03-01 with Technology & Engineering categories.
Metrology is an integral part of the structure of today’s world: navigation and telecommunications require highly accurate time and frequency standards; human health and safety relies on authoritative measurements in diagnosis and treatment, as does food production and trade; global climate studies also depend on reliable and consistent data. Moreover, international trade practices increasingly require institutions to display demonstrated conformity to written standards and specifications. As such, having relevant and reliable results of measurements and tests in compliance with mutually recognised standards can be a technical, commercial and statutory necessity for a company. This book, the results of a working group from the French College of Metrology and featuring chapters written by a range of experts from a variety of European countries, gives a comprehensive and international treatment of the subject. Academics involved in metrology as well as people involved in the metrology capacities of companies and institutions will find this book of great interest.
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.
Six Sigma for Medical Device Design is the first book to apply Six Sigma principles to the design of medical devices. Authored by experienced professionals, it uses real world examples and sample plans to provide a practical how-to guide for implementation. This volume also links the Six Sigma philosophy with the FDA's Design Control and ISO regulations, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. This book is an excellent tool for technical and scientific personnel to understand the realities of business and markets, to comply with stringent quality and safety standards, and to optimize the product realization process.
Outcomes Measurement
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Author : Candace L. Littell
language : en
Publisher:
Release Date : 1990
Outcomes Measurement written by Candace L. Littell and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1990 with Medical care categories.
Industrial Metrology For The Aviation Industry
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Author : Robert Roithmeier
language : en
Publisher: Carl Zeiss AG
Release Date :
Industrial Metrology For The Aviation Industry written by Robert Roithmeier and has been published by Carl Zeiss AG this book supported file pdf, txt, epub, kindle and other format this book has been release on with Education categories.
Quality assurance in aviation and space industry poses extraordinary challenges for measurement engineers. High standards for safety-critical parts must be maintained without reducing manufacturing speed and overall productivity. At the same time, the demands on the aerospace industry to develop aircraft that are as fuel-efficient and quiet as possible have increased enormously. And the aerospace industry wants to meet these requirements, whether in terms of noise emissions or fuel consumption. This is where industrial metrology with all its inspection capabilities, sensors and software solutions can make a valuable contribution. These possibilities are shown in this book. The demands placed on the aerospace industry are reinforced by strict regulations and approval processes – including additional specifications, traceability, conformity and certification standards. Be it EN/AS 9100, NadCap, test procedures according to AS 13003, 13006, EN/AS 9138 or others, the implementation of these procedures with coordinate measuring systems is part of this book.