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 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 Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry written by Eugenia Gabriela Carrillo-Cedillo and published by . This book was released on 2022 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards so as not to cause problems to the health of patients"--
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 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Inspection of Medical Devices written by Almir Badnjević and published by Springer. This book was released on 2023-11-27 with total page 0 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 Device Good Manufacturing Practices written by United States. Bureau of Medical Devices. Division of Compliance Programs and published by . This book was released on 1979 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry written by Carrillo-Cedillo, Eugenia Gabriela and published by IGI Global. This book was released on 2022-03-18 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Industrial Metrology written by Graham T. Smith and published by Springer Science & Business Media. This book was released on 2013-04-17 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: The subject of this book is surface metrology, in particular two major aspects: surface texture and roundness. It has taken a long time for manufacturing engineers and designers to realise the usefulness of these features in quality of conformance and quality of design. Unfortunately this awareness has come at a time when engineers versed in the use and specification of surfaces are at a premium. Traditionally surface metrology usage has been dictated by engineers who have served long and demanding apprenticeships, usually in parallel with studies leading to technician-level qualifications. Such people understood the processes and the achievable accuracies of machine tools, thereby enabling them to match production capability with design requirements. This synergy, has been made possible by the understanding of adherence to careful metrological procedures and a detailed knowledge of surface measuring instruments and their operation, in addition to wider inspection room techniques. With the demise in the UK of polytechnics and technical colleges, this source of skilled technicians has all but dried up. The shortfall has been made up of semi skilled craftsmen, or inexperienced graduates who cannot be expected to satisfy tradition al or new technology needs. Miniaturisation, for example, has had a pro found effect. Engineering parts are now routinely being made with nanometre surface texture and fiatness. At these molecular and atomic scales, the engineer has to be a physicist.
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 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 Metrology in Industry written by French College of Metrology and published by John Wiley & Sons. This book was released on 2013-03-01 with total page 187 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-01-01 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
Download or read book Fast Facts Digital Medicine written by A. Coravos and published by Karger Medical and Scientific Publishers. This book was released on 2020-04-03 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technology is changing how we practice medicine. Sensors and wearables are getting smaller and cheaper, and algorithms are becoming powerful enough to predict medical outcomes. Yet despite rapid advances, healthcare lags behind other industries in truly putting these technologies to use. A major barrier is the cross-disciplinary approach required to create digital tools, a process that requires knowledge from many people across a range of fields. 'Fast Facts: Digital Medicine – Measurement' aims to overcome that barrier, introducing the reader to core concepts and terms and facilitating dialogue. Contrasting 'clinical research' with routine 'clinical care', this short colorful book describes types of digital measurement and how to use and validate digital measures in different settings. And with the burgeoning development of digital medicine tools, the authors provide a timely overview of the security, ethical, regulatory and legal issues to be considered before a product can enter the market. Contents: • What is digital medicine? • Where does digital medicine fit? • Regulatory considerations • Ethical principles and our responsibilities • Ethics in practice • Security, data rights and governance • Digital biomarkers and clinical outcomes • Measurement in clinical trials • Verification and validation • The future of digital medicine
Download or read book Industrial Metrology written by Graham T. Smith and published by Springer Science & Business Media. This book was released on 2002-06-13 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: The subject of this book is surface metrology, in particular two major aspects: surface texture and roundness. It has taken a long time for manufacturing engineers and designers to realise the usefulness of these features in quality of conformance and quality of design. Unfortunately this awareness has come at a time when engineers versed in the use and specification of surfaces are at a premium. Traditionally surface metrology usage has been dictated by engineers who have served long and demanding apprenticeships, usually in parallel with studies leading to technician-level qualifications. Such people understood the processes and the achievable accuracies of machine tools, thereby enabling them to match production capability with design requirements. This synergy, has been made possible by the understanding of adherence to careful metrological procedures and a detailed knowledge of surface measuring instruments and their operation, in addition to wider inspection room techniques. With the demise in the UK of polytechnics and technical colleges, this source of skilled technicians has all but dried up. The shortfall has been made up of semi skilled craftsmen, or inexperienced graduates who cannot be expected to satisfy tradition al or new technology needs. Miniaturisation, for example, has had a pro found effect. Engineering parts are now routinely being made with nanometre surface texture and fiatness. At these molecular and atomic scales, the engineer has to be a physicist.
