Download or read book Medical Device Product Lifecycle written by Bernadette White and published by Independently Published. This book was released on 2022-03-11 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to provide an introduction to the application of a lifecycle approach to product design and development for medical devices. Medical Device Product Lifecycle management provides a framework to develop, design maintain user requirements and ensure the safety and performance of medical devices. Application of a Medical Device Product Lifecycle Management benefits the business aspects of manufacturing, fosters alignment across design and development teams and incorporates the voice of the customer, taking into account their needs and safety that is inherent in the design of products. The Medical Device Product Lifecycle (MDPL) relies upon several distinct quality management elements and processes in order to function effectively. These include; principles and establishment of a quality management system, regulatory processes, validation processes, engineering processes, change management and risk management processes. The MDPL process itself requires procedures and documentation to facilitate product realization. For the reader to gain the maximum benefit from this book, the following points should be considered. To begin with-Regulations are mandatory. Medical devices range in their application (intended use and indications), technologies, principles of operation, complexity and value. However, regulation in addition to standards need to be consulted and applied within organizations. The manufacturer has a legal responsibility in this regard and the classification and commercial strategy may require regulations such as FDA 21 CFR 820, (United States), and Medical Device Regulations EU MDR (2017/745) or Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) (in Europe). Introduction Establishing a Medical Device Product Development Process is necessary to for medical device manufacturers to meet FDA regulations and regional regulations applicable to the products for sale. Beyond the legal stipulation, an additional purpose is to realize and deliver safe and effective medical devices that meet the intended use and user needs which provides medical solutions that enhance and preserve quality of life. To achieve safe and effective products, the guiding principles and techniques not only need to be applied in the design and development stages, but maintaining and monitoring the performance through the product lifecycle is required. It is easily to compartmentalize product performance and safety as a development and design-based activity, however, an effective medical device lifecycle process must ensure design safety and continuity until product retirement and discontinuation. The introduction of new medical device products or changes to existing medical device products necessitate design and development activities in order to plan and deliver the appropriate verifications and validations to demonstrate safety and performance of products. Device manufacturers in establishing and applying a Medical Device Product Lifecycle Process must continually ensure the process is fit-for-purpose and that is fulfils its legal and regulatory obligations (e.g. meeting the requirements of 21 CFR 820.30: Medical Devices - Quality System Regulation and ISO 13485: Medical Devices- Quality Management Systems etc.) A Medical Device Product Lifecycle process must be a comprehensive, end-to-end process that encompasses the entire life cycle of a product from project initiation through to product discontinuation and retirement of a marketed product. Making a comprehensive and detailed process intuitive and easy-to-apply should also play a role in designing and maintaining a MDPL process. Structuring the process into specific stages and the use of design review or gate reviews also provides for a format that has milestones and a stage by stage approach that makes it easier for engineers to work with.

Download or read book Managing Medical Devices within a Regulatory Framework written by Beth Ann Fiedler and published by Elsevier. This book was released on 2016-09-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements.

Download or read book Public Health Effectiveness of the FDA 510 k Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Download or read book Trends in Development of Medical Devices written by Prakash Srinivasan Timiri Shanmugam and published by Academic Press. This book was released on 2020-01-25 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities

Download or read book Medical Device Cybersecurity for Engineers and Manufacturers written by Axel Wirth and published by Artech House. This book was released on 2020-08-31 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed with urgency. In the end, this is about preventing patient harm and preserving patient trust. A comprehensive guide to medical device secure lifecycle management, this is a book for engineers, managers, and regulatory specialists. Readers gain insight into the security aspects of every phase of the product lifecycle, including concept, design, implementation, supply chain, manufacturing, postmarket surveillance, maintenance, updates, and end of life. Learn how to mitigate or completely avoid common cybersecurity vulnerabilities introduced during development and production. Grow your awareness of cybersecurity development topics ranging from high-level concepts to practical solutions and tools. Get insight into emerging regulatory and customer expectations. Uncover how to minimize schedule impacts and accelerate time-to-market while still accomplishing the main goal: reducing patient and business exposure to cybersecurity risks. Medical Device Cybersecurity for Engineers and Manufacturers is designed to help all stakeholders lead the charge to a better medical device security posture and improve the resilience of our medical device ecosystem.

Download or read book Innovation and Protection written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

Download or read book Medical Device Product Life Cycle Management written by Vinny Sastri and published by Wiley-Scrivener. This book was released on 2013-06-18 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Product Lifecycle Management written by John Stark and published by Springer Science & Business Media. This book was released on 2011-08-12 with total page 573 pages. Available in PDF, EPUB and Kindle. Book excerpt: Product Lifecycle Management (2nd edition) explains what Product Lifecycle Management (PLM) is, and why it's needed. It describes the environment in which products are developed, realised and supported, before looking at the basic components of PLM, such as the product, processes, applications, and people. The final part addresses the implementation of PLM, showing the steps of a project or initiative, and typical activities. This new and expanded edition of Product Lifecycle Management is fully updated to reflect the many advances made in PLM since the release of the first edition. It includes descriptions of PLM technologies and examples of implementation projects in industry. Product Lifecycle Management will broaden the reader’s understanding of PLM, nurturing the skills needed to implement PLM successfully and to achieve world-class product performance across the lifecycle. “A 20-year veteran of PLM, I highly recommend this book. A clear and complete overview of PLM from definition to implementation. Everything is there - reasons, resources, strategy, implementation and PLM project management.” Achim Heilmann, Manager, Global Technical Publications, Varian Medical Systems “Product Lifecycle Management is an important technology for European industry. This state-of-the art book is a reference for those implementing and researching PLM.” Dr. Erastos Filos, Head of Sector "Intelligent Manufacturing Systems", European Commission “This book, written by one of the best experts in this field, is an ideal complement for PLM courses at Bachelor and Master level, as well as a well-founded reference book for practitioners.” Prof. Dr.-Ing. Dr. h.c. Sandor Vajna, University of Magdeburg, Germany “This comprehensive book can help drive an understanding of PLM at all levels – from CEOs to CIOs, and from professors to students – that will help this important industry continue to expand and thrive.” James Heppelmann, President and Chief Executive Officer, PTC “PLM is a mission-critical decision-making system leveraged by the world’s most innovative companies to transform their process of innovation on a continuous basis. That is a powerful value proposition in a world where the challenge is to get better products to the market faster than ever before. That is the power of PLM.” Tony Affuso, Chairman and CEO, Siemens PLM Software

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Download or read book Medical Device Software Verification Validation and Compliance written by David A. Vogel and published by Artech House. This book was released on 2011 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."

Download or read book Product Lifecycle Management for Society written by Alain Bernard and published by Springer. This book was released on 2013-11-09 with total page 743 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 10th IFIP WG 5.1 International Conference on Product Lifecycle Management, PLM 2013, held in Nantes, France, in July 2013. The 63 full papers presented together with 2 keynote talks were carefully reviewed and selected from 91 submissions. They are organized in the following topical sections: PLM for sustainability, traceability and performance; PLM infrastructure and implementation processes; capture and reuse of product and process information; PLM and knowledge management; enterprise system integration; PLM and influence of/from social networks; PLM maturity and improvement concepts; PLM and collaborative product development; PLM virtual and simulation environments; and building information modeling.

Download or read book Medical Device Quality Management Systems written by Susanne Manz and published by Academic Press. This book was released on 2018-09-27 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans

Download or read book Medical Device Regulation written by Elijah Wreh and published by Elsevier. This book was released on 2023-02-22 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations

Download or read book Product Lifecycle Management Volume 4 The Case Studies written by John Stark and published by Springer. This book was released on 2019-05-07 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents some twenty case studies, showing how companies in different industry sectors and of different sizes make advances in Product Lifecycle Management (PLM). Like the author’s previous volumes, this book provides a valuable resource for those wishing to learn about PLM and how to implement and apply it in their companies. Helping readers to · learn about implementing and benefiting from PLM; · learn about good PLM solutions and best practice; · improve their planning and decision-making abilities; · benefit from the lessons learned by the companies featured in the case studies; · proceed faster and further with PLM the book presents effective PLM solutions and best practices. At the same time, the case studies included demonstrate how different companies implement and benefit from PLM. Each case study is addressed in a separate chapter and details a different situation, enabling readers to put themselves in the situation and think through different actions and decisions. A valuable resource for PLM team managers and employees in engineering and manufacturing companies, the book is also of interest to researchers and students in industrial engineering fields.

Download or read book Update on Life Cycle Strategy for New Implants and Medical Devices written by Marvi Sri Harwoko and published by Smithers Rapra. This book was released on 2012-10-31 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the emergence of new therapies for diseases which affect vital organs either partially or as a whole, the complexity of the parameter interaction and the variety of new discoveries opens many possibilities to implement these proposals into clinical use. Unfortunately, this diversity can also handicap an efficient design process.Therefore, a practical tool has to be developed, which in the early development stages, systematically supports the product and process optimization by preparing and providing information and knowledge.This book details such a methodology for systematizing the product design process, which uses a knowledge-based design process, a customer-oriented engineering process, and a business supporting life cycle model.This book describes how this methodology can be used as a product design guidance tool for supporting the development of a new implant. The methodology resolves the development complexity by using a series of logical steps and provides researchers with the means to assess these steps as soon as possible for anticipating and removing subsequent useless steps.

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 Product Lifecycle Management Driving the Next Generation of Lean Thinking written by Michael Grieves and published by McGraw Hill Professional. This book was released on 2005-11-16 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Product Lifecycle Management (PLM) is the newest wave in productivity. This revolutionary approach is an outcome of lean thinking; however, PLM eliminates waste and efficiency across all aspects of a product's life--from design to deployment--not just in its manufacture. By using people, product information, processes, and technology to reduce wasted time, energy, and material across an organization and into the supply chain, PLM drives the next generation of lean thinking. Now PLM pioneer Michael Grieves offers everyone from Six Sigma and lean practitioners to supply chain managers, product developers, and consultants a proven framework for adopting this information-driven approach. Product Lifecycle Management shows you how to greatly enhance your firm's productivity by integrating the efforts of your entire organization. Most companies are seeing the returns of their efforts in lean methods diminishing, as the most fruitful applications have already been addressed. Here, Grieves reveals how PLM gives you an opportunity to make improvements both within and across functional areas in order to increase agility, optimize efficiency, and reduce costs across the board. He gives you the most comprehensive view of PLM available, fully outlining its characteristics, method, and tools and helping you assess your organizational readiness. There's also proven examples from the field, where PLM is being widely adopted by leading companies, including General Motors, General Electric, and Dell, that are widely adopting the approach. You'll see how PLM has saved these companies billions in unnecessary costs and shaved as much as 60% off cycle times. With this book you'll learn how to: Develop and implement your PLM strategy to support your corporate objectives Engage all your employees in using information to eliminate waste Enable improved information flow Better organize and utilize your intellectual capital Foster an environment that drives PLM Lean manufacturing can only take your organization so far. To bring your productivity to the next level and save remarkable amounts of time, money, and resources, Product Lifecycle Management is your one-stop, hands-on guide to implementing this powerful methodology.