Download or read book Medical Device Packaging Handbook Revised and Expanded written by Max Sherman and published by CRC Press. This book was released on 1998-08-25 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound packaging and disposal procedures, storage autoclave sytems, international standards, customer needs, regulatory aspects, and more.
Download or read book Medical Device Packaging Handbook Second Edition Revised and Expanded written by Max Sherman and published by . This book was released on 1998 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: "This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound packaging and disposal procedures, storage autoclave sytems, international standards, customer needs, regulatory aspects, and more."--Provided by publisher.
Download or read book The Medical Device R D Handbook Second Edition written by Theodore R. Kucklick and published by CRC Press. This book was released on 2012-12-05 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving. The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. The text also contains interviews with leaders in the industry who offer their vast experience and insights on how to start and grow successful companies—both what works and what doesn’t work. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.
Download or read book Medical Device Packaging Handbook written by Joseph D. O'Brien and published by . This book was released on 1990 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to help manufacturers, engineers, designers, and suppliers of medical products evaluate the design, materials, and technology of their packaging. Highlights recent developments in the field, and presents information on current industry standards and practices, and regulation. Provides details of materials and specifications, sterilization methods, distribution test cycles, labeling criteria, bar coding, autoclave systems, and other topics. Annotation(c) 2003 Book News, Inc., Portland, OR (booknews.com)
Download or read book Medical Device Design written by Peter J. Ogrodnik and published by Academic Press. This book was released on 2019-10-30 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns
Download or read book The Medical Device Validation Handbook Second Edition written by Max Sherman and published by . This book was released on 2018-06-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Packaging Handbook written by Edward Bauer and published by CRC Press. This book was released on 2009-03-24 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Packaging Handbook provides a complete overview of the role that packaging plays in the development and delivery of pharmaceuticals and medical devices. Supplying a thorough examination of the industry in size and scope, the book covers drug dosage forms, vaccines, biologically produced products, and medical foods. Features: Discusses how packaging is designed and integrated into the product development cycle Provides an overview of the regulatory environment procedures Describes the materials used to package pharmaceuticals, including glass, metal, plastics, flexible films, rubber, and elastomers Examines new hybrids used for packaging Explores the processing techniques used with the materials to produce pharmaceutical containers Discusses some of the strengths and weaknesses of the processes used for container fabrication Explains retort, aseptic, gas, and radiation sterilization of product Reviews labeling and design for pharmaceuticals, including how labels are produced, materials used, and production techniques Complete and straightforward, the book lists information in an easy to follow fashion, making it a complete standalone reference for anyone working in the pharmaceutical industry.
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 376 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
Download or read book Handbook of Polypropylene and Polypropylene Composites Revised and Expanded written by Harutun Karian and published by CRC Press. This book was released on 2003-03-25 with total page 685 pages. Available in PDF, EPUB and Kindle. Book excerpt: Building on the success of its predecessor with completely revised material and six new chapters, the Handbook of Polypropylene and Polypropylene Composites, Second Edition responds to increasing interest and changing global trends in the manufacture and application of polypropylene resin. The authors highlight viable options for the manufacture of
Download or read book The Medical Device R D Handbook written by Theodore R. Kucklick and published by . This book was released on 2013 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Written for medical device designers, biomedical engineering students, physician entrepreneurs, and medical device entrepreneurs, this reference explains the basics on how to prototype and develop a medical device. It discusses the basics of plastics, adhesives, medical needles, and rapid prototyping as well as tips and tools to save time and money. This updated and expanded second edition includes practical advice and interviews from key opinion leaders and pioneers in the field. Extensive references at the end of each chapter enhance additional study"--Provided by publisher.
Download or read book Labs on Chip written by Eugenio Iannone and published by CRC Press. This book was released on 2018-09-03 with total page 1178 pages. Available in PDF, EPUB and Kindle. Book excerpt: Labs on Chip: Principles, Design and Technology provides a complete reference for the complex field of labs on chip in biotechnology. Merging three main areas— fluid dynamics, monolithic micro- and nanotechnology, and out-of-equilibrium biochemistry—this text integrates coverage of technology issues with strong theoretical explanations of design techniques. Analyzing each subject from basic principles to relevant applications, this book: Describes the biochemical elements required to work on labs on chip Discusses fabrication, microfluidic, and electronic and optical detection techniques Addresses planar technologies, polymer microfabrication, and process scalability to huge volumes Presents a global view of current lab-on-chip research and development Devotes an entire chapter to labs on chip for genetics Summarizing in one source the different technical competencies required, Labs on Chip: Principles, Design and Technology offers valuable guidance for the lab-on-chip design decision-making process, while exploring essential elements of labs on chip useful both to the professional who wants to approach a new field and to the specialist who wants to gain a broader perspective.
Download or read book Practical Guide to the Packaging of Electronics Second Edition written by Ali Jamnia and published by CRC Press. This book was released on 2008-12-01 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the demand for packaging more electronic capabilities into smaller packages rises, product developers must be more cognizant of how the system configuration will impact its performance. Practical Guide to the Packaging of Electronics: Second Edition, Thermal and Mechanical Design and Analysis provides a basic understanding of the issues that concern the field of electronics packaging. First published in 2003, this book has been extensively updated, includes more detail where needed, and provides additional segments for clarification. This volume supplies a solid foundation for heat transfer, vibration, and life expectancy calculations. Topics discussed include various modes of heat removal, such as conduction, radiation, and convection; the impact of thermal stresses; vibration and the resultant stresses; shock management; mechanical, electrical, and chemically induced reliability; and more. Unlike many other available works, it neither assumes the reader’s familiarity with the subject nor is it so basic that the reader may lose interest. Dr. Ali Jamnia has published a large number of engineering papers and presentations and is the holder of a number of patents and patent applications. He has been involved in the issues of electronics packaging since the early ‘90s and since 1995 has worked toward the development of innovative electronics systems to aid individuals with physical or cognitive disabilities. By consulting this manual, engineers, program managers, and quality assurance managers involved in electronic systems gain a fundamental grasp of the issues involved in electronics packaging, learn how to define guidelines for a system’s design, develop the ability to identify reliability issues and concerns, and are able to conduct more complete analyses for the final design.
Download or read book International Labeling Requirements for Medical Devices Medical Equipment and Diagnostic Products written by Charles Sidebottom and published by CRC Press. This book was released on 2019-08-30 with total page 616 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more.
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2018-03-28 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
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 490 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 Design Controls for the Medical Device Industry Second Edition written by Marie B. Teixeira and published by CRC Press. This book was released on 2013-11-12 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The ASQ Certified Medical Device Auditor Handbook written by Scott A Laman and published by Quality Press. This book was released on 2021-02-05 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: • A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) • Current information about federal and international regulations • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations • A thorough explanation of quality tools and techniques
