Download or read book A Beginners Road Map to the Medical Device Industry written by Shalinee Naidoo and published by Arcler Press. This book was released on 2021-12 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: It is estimated that there are over 10 000 different medical devices available on the market today. These devices have become an integral part of health care and a vital component of the various activities carried out by health-care providers to treat people with varying medical conditions all around the world. Regulatory requirements for such devices differ from country to country all around the world which in turn make it difficult for manufacturers to obtain all round market approval for their products. While market approval from regulatory authorities can easily be obtained if a manufacturer can prove the device meets national regulatory guidelines; differences in regulatory requirements between different countries means that a manufacturer's registration process becomes more complex and ultimately may require additional resources or information. This volume aims to provide a basic roadmap to beginners into the medical device industry. It provides a simplistic overview of the vast history behind much of the regulations and medical technology governing the field today as well as the need and importance of associated medical device regulations and essential principles governing safe and effective manufacture and use of these devices.
Download or read book Medical Device Regulations Roadmap written by Des O'Brien and published by Createspace Independent Publishing Platform. This book was released on 2017-10-11 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the Engineer or scientist starting out in Medical devices, the array of regulation across the globe can be daunting. Many companies also need to fulfill regulation from multiple jurisdictions. Some requirements of Design, GMP and manufacturing are common. FDA and European market requires provide a framework for medical device manufacturers to certain requirements that ensure patient safety. This short book introduces the key themes associated with Medical Device Regulation. While the online world provides a detailed and perrinial source of current information and regulations, it is often hard to know where to start. This concise book provides that introduction and provides in a physical format that is a useful companion for the Engineer or Medical Device Professional. (Page Count 112)
Download or read book A Beginners Road Map to the Medical Device Industry written by Shalinee Naidoo (author) and published by . This book was released on 1901 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Design Controls for the Medical Device Industry Third Edition written by Marie B. Teixeira and published by CRC Press. This book was released on 2019-08-02 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the 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. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements
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 Making Innovation Work written by Tony Davila and published by FT Press. This book was released on 2012-11-09 with total page 545 pages. Available in PDF, EPUB and Kindle. Book excerpt: Profitable innovation doesn’t just happen. It must be managed, measured, and properly executed, and few companies know how to accomplish this effectively. Making Innovation Work presents a formal innovation process proven to work at HP, Microsoft and Toyota, to help ordinary managers drive top and bottom line growth from innovation. The authors have drawn on their unsurpassed innovation consulting experience -- as well as the most thorough review of innovation research ever performed. They'll show what works, what doesn't, and how to use management tools to dramatically increase the payoff from innovation investments. Learn how to define the right strategy for effective innovation; how to structure an organization to innovate best; how to implement management systems to assess ongoing innovation; how to incentivize teams to deliver, and much more. This book offers the first authoritative guide to using metrics at every step of the innovation process -- from idea creation and selection through prototyping and commercialization. This updated edition refreshes the examples used throughout the book and features a new introduction that gives currency to the principles covered throughout.
Download or read book Medical Device Marketing written by Terri Wells and published by . This book was released on 2010 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Insider's Guide to Success in this Unique Industry To make it in the competitive and fast-changing medical device industry, you need to be armed with the best information available. That's where Medical Device Marketing comes in. With more than 20 years' experience in the business, author Terri Wells outlines a complete road map for a successful product cycle-from development to phase-out. You'll learn: How to identify the customer-and why this seemingly simple task is trickier than it sounds. Steps to a winning business plan-from conducting insightful market research to making accurate cost projections. Keys to product development-along with what to do when the unexpected happens. Effective sales support-including what you really need to know about how every sales team operates. How to get product launches right-as well as the communication tips that will make or break a great product. Tactics for managing existing product lines-and how to boost sales during a plateau. Insider advice for a successful career-and the key behaviors you must always, absolutely avoid in order to keep it. Much, much more! Whether you are aiming for a product management position or are a longtime veteran, Medical Device Marketing is the unique and up-to-the-minute guidebook for this exciting business. It's packed with real-life examples, sample charts and marketing plans, and-most importantly-keen insight you won't find anywhere else."
Download or read book A Road Map for Scaling Private Sector Financing for the Blue Economy in Thailand written by Asian Development Bank and published by Asian Development Bank. This book was released on 2023-10-01 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analyzing the importance of Thailand’s blue economy, this report considers ways to mobilize and scale up private sector investment in areas such as aquaculture and marine renewable energy to help bolster sustainable blue development. It explains why factors such as limited awareness of ocean economy opportunities, a lack of investment-ready at-scale projects, and insufficient monitoring are proving a barrier to investors. The report shows how creating an enabling environment and developing products such as sustainability-linked loans and technical assistance grants could help drive investment flows to the sector and safeguard Thailand’s blue economic growth.
Download or read book Introduction to Medical Software written by Xenophon Papademetris and published by Cambridge University Press. This book was released on 2022-05-05 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing a concise and accessible overview of the design, implementation and management of medical software, this textbook will equip students with a solid understanding of critical considerations for both standalone medical software (software as a medical device/SaMD) and software that is integrated into hardware devices. It includes: practical discussion of key regulatory documents and industry standards, and how these translate into concrete considerations for medical software design; detailed coverage of the medical software lifecycle process ; accessible introduction to quality and risk management systems in the context of medical software; succinct coverage of essential topics in data science, machine learning, statistics, cybersecurity, software engineering and healthcare bring readers up-to-speed; six cautionary real-world case studies illustrate the dangers of improper or careless software processes. Accompanied by online resources for instructors, this is the ideal introduction for undergraduate students in biomedical engineering, electrical engineering and computer science, junior software engineers, and digital health entrepreneurs.
Download or read book Mobile Health written by Sasan Adibi and published by Springer. This book was released on 2015-02-18 with total page 1160 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a comprehensive report on the technological aspects of Mobile Health (mHealth) and discusses the main challenges and future directions in the field. It is divided into eight parts: (1) preventive and curative medicine; (2) remote health monitoring; (3) interoperability; (4) framework, architecture, and software/hardware systems; (5) cloud applications; (6) radio technologies and applications; (7) communication networks and systems; and (8) security and privacy mechanisms. The first two parts cover sensor-based and bedside systems for remotely monitoring patients’ health condition, which aim at preventing the development of health problems and managing the prognosis of acute and chronic diseases. The related chapters discuss how new sensing and wireless technologies can offer accurate and cost-effective means for monitoring and evaluating behavior of individuals with dementia and psychiatric disorders, such as wandering behavior and sleep impairments. The following two parts focus on architectures and higher level systems, and on the challenges associated with their interoperability and scalability, two important aspects that stand in the way of the widespread deployment of mHealth systems. The remaining parts focus on telecommunication support systems for mHealth, including radio technologies, communication and cloud networks, and secure health-related applications and systems. All in all, the book offers a snapshot of the state-of-art in mHealth systems, and addresses the needs of a multidisciplinary audience, including engineers, computer scientists, healthcare providers, and medical professionals, working in both academia and the industry, as well as stakeholders at government agencies and non-profit organizations.
Download or read book Biomaterials Science written by Buddy D. Ratner and published by Academic Press. This book was released on 2012-12-31 with total page 1573 pages. Available in PDF, EPUB and Kindle. Book excerpt: The revised edition of this renowned and bestselling title is the most comprehensive single text on all aspects of biomaterials science. It provides a balanced, insightful approach to both the learning of the science and technology of biomaterials and acts as the key reference for practitioners who are involved in the applications of materials in medicine. Over 29,000 copies sold, this is the most comprehensive coverage of principles and applications of all classes of biomaterials: "the only such text that currently covers this area comprehensively" - Materials Today Edited by four of the best-known figures in the biomaterials field today; fully endorsed and supported by the Society for Biomaterials Fully revised and expanded, key new topics include of tissue engineering, drug delivery systems, and new clinical applications, with new teaching and learning material throughout, case studies and a downloadable image bank
Download or read book Developing an ISO 13485 Certified Quality Management System written by Ilkka Juuso and published by CRC Press. This book was released on 2022-03-20 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects. In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS.
Download or read book Understanding Medical Devices an Introduction to the Medical Device Industry written by Shalinee Naidoo and published by Arcler Press. This book was released on 2019-11 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understanding Medical Devices: An introduction to the medical device industry throws light on the meaning of medical devices and the effects that the global trends have on their usage and demand. It informs about the research that is aimed at improving the medical devices and the various solutions to overcome the barriers in the choosing of medical devices. The book makes the readers understand the various guidelines for medical device donations and throws light on the importance of public health in this sector. Also discussed in the book are the examples of various medical devices, the essential principles of safety and performance, the use of standards by the regulatory bodies, the various phases of medical device development, the responsible entity for the medical devices and the way the medical device industry has globalized.
Download or read book Biomedical Sensors and Smart Sensing written by Ayan Kumar Panja and published by Academic Press. This book was released on 2022-06-02 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Sensors and Smart Sensing: A Beginner’s Guide, a book in the 10-volume Primers in Biomedical Imaging Devices and Systems series, covers a wide range of interdisciplinary applications in imaging modalities, nuclear medicine, computed tomographic systems, x-ray systems, magnetic resonance imaging, ultrasound, and virtual reality. The series explores the essential fundamental techniques required to analyze and process signals and images for diagnosis, scientific discovery and medical applications. Volumes in this series cover a wide range of interdisciplinary areas, combining foundational content with practical case studies to demonstrate the applications of these technologies in real-world situations. In addition, the 10-volume series considers various medical devices, electronics, circuits, sensors and algorithms. Several applications ranging from basic biological science to clinical practice are included to facilitate ongoing research. Covers a variety of sensing and signal processing techniques Introduces different approaches relating to communication and intelligent data processing for early detection and prediction of diseases Includes practical case studies
Download or read book Driving Innovation and Job Growth Through the Life Sciences Industry written by United States. Congress. Joint Economic Committee and published by . This book was released on 2011 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Third International Conference on the Development of Biomedical Engineering in Vietnam written by Vo Van Toi and published by Springer Science & Business Media. This book was released on 2010-04-03 with total page 339 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vietnam is a rapidly developing, socially dynamic country, where interest in biomedical engineering activities has grown considerably in recent years. The leadership of the Vietnamese government, and of research and educational institutions, are well aware of the importance of this field for the development of the country and have instituted policies to promote its development. The political, economic and social environment within the country offers unique opportunities for the international community and this conference was intended to provide a vehicle for the sharing of experiences; development of support and collaboration networks for research; and exchange of ideas on how to improve the educational and entrepreneurial environment to better address the urgent needs of Vietnam. In January 2004, under the sponsorship of the U.S. National Science Foundation, a U.S. delegation that consisted of Biomedical Engineering professors from different universities in the United States, visited several universities and research institutions in Vietnam to assess the state of development of this field. This delegation proposed a five year plan that was enthusiastically embraced by the international scientific communities to actively develop collaborations with Vietnam. Within this framework, in July 2005, the First International Conference on the Development of Biomedical Engineering in Vietnam was held in Ho Chi Minh City. From that conference a Consortium of Vietnam-International Universities was created to advise and assist the development of Biomedical Engineering in Vietnamese universities.
