Download or read book Industrial Metrology for Medical Products and Devices written by Robert Roithmeier and published by Carl Zeiss AG. This book was released on with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Industrial Metrology for Medical Products and Devices written by Robert Dr. Roithmeier and published by . This book was released on 2020 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Devices Measurements Quality Assurance and Standards written by Cesar Augusto Caceres and published by ASTM International. This book was released on 1983 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Inspection of Medical Devices written by Almir Badnjević and published by Springer Nature. This book was released on 2023-12-28 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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!

Download or read book Design Controls for the Medical Device Industry written by Marie B. Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Statistical Procedures for the Medical Device Industry written by Wayne A. Taylor and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Device Design for Six Sigma written by Basem El-Haik and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Industrial Metrology for the Aviation Industry written by Robert Roithmeier and published by Carl Zeiss AG. This book was released on with total page 149 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Download or read book Measuring the Physiologic Use Conditions of Medical Devices written by Walt Baxter and published by Springer. This book was released on 2024-08-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The physiologic use conditions medical devices are subjected to during implant and long-term in vivo use are critical to ensuring device reliability, efficacy, and safety. This book highlights advanced analyses for measuring the physiologic use conditions of medical devices, introducing important challenges facing engineers. The chapters include: A working definition for the physiologic in vivo use conditions used to further improve medical device performance in patients. Introductions to common approaches used to measure medical device use conditions so that engineers can use similar techniques where useful. Detailed case studies that highlight problem statements, approaches for measuring physiologic use conditions, and example outputs from such analyses. This book provides an up-to-date resource for device engineers so that they can accurately measure conditions that devices experience during and after implantation—key to reliability testing, computational modeling, and choosing optimum designs. This is an ideal book for medical device engineers and scientists designing and manufacturing devices for human use, students interested in understanding how devices interact with anatomy, and academic researchers seeking to apply advanced analyses to unmet use condition needs in the medical device field.

Download or read book Six Sigma for Medical Device Design written by Jose Justiniano and published by CRC Press. This book was released on 2004-11-15 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Patient Centered Measurement written by Leah M. McClimans and published by Oxford University Press. This book was released on 2024 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patients often are asked to fill out questionnaires before or after going to the doctor's office or hospital. What is the point of these questionnaires? Why do the questions often seem irrelevant? Does it matter if patients fill them out or ignore them? This book addresses these questions while also providing historical context about how these questionnaires became so popular. These questionnaires, which philosopher Leah M. McClimans calls 'Patient-Centered Measures' have a fascinating history that combines the contemporary emphasis in medical ethics on patient-centered care with the contemporary preoccupation with evidence-based medicine (the idea that medical decisions should be based on empirical evidence). Patient-centered measures sit between these two concerns and thus serve as an excellent example of a medical technology for the twenty-first century.

Download or read book Metrology for Inclusive Growth of India written by Dinesh K. Aswal and published by Springer Nature. This book was released on 2020-11-09 with total page 1084 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the significance of metrology for inclusive growth in India and explains its application in the areas of physical–mechanical engineering, electrical and electronics, Indian standard time measurements, electromagnetic radiation, environment, biomedical, materials and Bhartiya Nirdeshak Dravyas (BND®). Using the framework of “Aswal Model”, it connects the metrology, in association with accreditation and standards, to the areas of science and technology, government and regulatory agencies, civil society and media, and various other industries. It presents critical analyses of the contributions made by CSIR-National Physical Laboratory (CSIR-NPL), India, through its world-class science and apex measurement facilities of international equivalence in the areas of industrial growth, strategic sector growth, environmental protection, cybersecurity, sustainable energy, affordable health, international trade, policy-making, etc. The book will be useful for science and engineering students, researchers, policymakers and entrepreneurs.

Download or read book The Medical Device Industry written by Norman F. Estrin and published by CRC Press. This book was released on 1990-08-31 with total page 1020 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Medical Device Reliability and Associated Areas written by B.S. Dhillon and published by CRC Press. This book was released on 2000-03-29 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing,

Download or read book Medical Device Design and Regulation written by Carl T. DeMarco and published by Quality Press. This book was released on 2011-01-24 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use or for employee training. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the “MDDR Users Group” on LinkedIn.

Download or read book The Medical Device R D Handbook written by Theodore R. Kucklick and published by CRC Press. This book was released on 2005-11-21 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha