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 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 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 Formulation and Device Lifecycle Management of Biotherapeutics written by Beate Bittner and published by Academic Press. This book was released on 2022-01-14 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients. Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-related healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution. Summarizes formulation and device lifecycle management activities that enable customer-centric and sustainable drug delivery for biotherapeutics Describes the pharmacokinetic-based clinical development pathway for subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies Details established clinical development pathways supporting the approval of automated subcutaneous injection devices and proposes novel concepts Discusses how to realize home- and self-administration of biotherapeutics in cancer care Highlights aspects of multidisciplinary formulation and device lifecycle management that can be leveraged across different disease areas and introduces a decision architecture on when and how drug developers should embark into related development activities

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 Product Lifecycle Management PLM written by Uthayan Elangovan and published by CRC Press. This book was released on 2020-06-24 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: As featured on CNN, Forbes and Inc – BookAuthority identifies and rates the best books in the world, based on recommendations by the world's most successful business leaders and experts. Winning the spot of #19 out of 26 on the 2020 Bookauthority Best New Industrial Management Books of All Time. Winning the spot of #3 out of 8 on the 2021 Bookauthority Best New Industrial Management Books to Read in 2021. Winning the spot of #5 out of 11 on the 2021 Bookauthority Best New Product Design Books to Read in 2021. 2020 Taylor & Francis Award Winner for Outstanding Professional Book! Product Lifecycle Management (PLM): A Digital Journey Using Industrial Internet of Things (IIot) provides a summary of the essential topics of Product Lifecycle Management (PLM) and the Industrial Internet of Things (IIoT) in the era of Industry 4.0. The book discusses emerging technologies, their contribution towards enhancing product design, development, and manufacturing. It also presents the integration of PLM, Enterprise Resource Planning (ERP), and Manufacturing Execution System (MES) along with IIoT as well the integration of mechanical, electronic components, embedded systems, firmware and software focusing on smart design, development, and manufacturing in the digital transformation journey. The book provides a high-level overview of how the smart product development through smart manufacturing materializes within the smart ecosystem. Manufacturing professionals, designers, mechanical, electrical, electronics, instrumentation and industrial engineers, information and communication technology consultants and those working in production planning, process control, and operations will find this book invaluable.

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 Product Lifecycle Management written by Anselmi Immonen and published by Springer Science & Business Media. This book was released on 2013-06-05 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first English-language book on Product Lifecycle Management (PLM) that introduces the reader to the basic terms and fundamentals of PLM. The text provides a solid foundation for starting a PLM development project. It gives ideas and examples how PLM can be utilized in various industries. In addition, it also offers an insight into how PLM can assist in creating new business opportunities and in making real eBusiness possible.

Download or read book Product Lifecycle Management PLM in Transition Times The Place of Humans and Transformative Technologies written by Frédéric Noël and published by Springer Nature. This book was released on 2023-01-31 with total page 707 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 19th IFIP WG 5.1 International Conference, PLM 2022, Grenoble, France, July 10–13, 2022, Revised Selected Papers. The 67 full papers included in this book were carefully reviewed and selected from 94 submissions. They were organized in topical sections as follows: Organisation: Knowledge Management, Business Models, Sustainability, End-to-End PLM, Modelling tools: Model-Based Systems Engineering, Geometric modelling, Maturity models, Digital Chain Process, Transversal Tools: Artificial Intelligence, Advanced Visualization and Interaction, Machine learning, Product development: Design Methods, Building Design, Smart Products, New Product Development, Manufacturing: Sustainable Manufacturing, Lean Manufacturing, Models for Manufacturing.

Download or read book Product Lifecycle Management Green and Blue Technologies to Support Smart and Sustainable Organizations written by Osiris Canciglieri Junior and published by Springer Nature. This book was released on 2022-02-08 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: The two-volume set IFIP AICT 639 and 640 constitutes the refereed post-conference proceedings of the 18th IFIP WG 5.1 International Conference on Product Lifecycle Management, PLM 2021, held in Curitiba, Brazil, during July 11-14, 2021. The conference was held virtually due to the COVID-19 crisis. The 107 revised full papers presented in these proceedings were carefully reviewed and selected from 133 submissions. The papers are organized in the following topical sections: Volume I: Sustainability, sustainable development and circular economy; sustainability and information technologies and services; green and blue technologies; AI and blockchain integration with enterprise applications; PLM maturity, PLM implementation and adoption within industry 4.0; and industry 4.0 and emerging technologies: Volume II: Design, education and management; lean, design and innovation technologies; information technology models and design; and models, manufacturing and information technologies and services.

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 GAMP 5 written by Sion Wyn and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.

Download or read book Product Lifecycle Management and the Industry of the Future written by José Ríos and published by Springer. This book was released on 2017-12-19 with total page 731 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed post-conference proceedings of the 14th IFIP WG 5.1 International Conference on Product Lifecycle Management, PLM 2017, held in Seville, Spain, in July 2017. The 64 revised full papers presented were carefully reviewed and selected from 78 submissions. The papers are organized in the following topical sections: PLM maturity, implementation and adoption; PLM for digital factories; PLM and process simulation; PLM, CAX and knowledge management; PLM and education; BIM; cyber-physical systems; modular design and products; new product development; ontologies, knowledge and data models; and Product, Service, Systems (PSS).

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 Project Portfolios in Dynamic Environments written by Brian Hobbs and published by Project Management Institute. This book was released on 2012-05-01 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: Project Portfolios in Dynamic Environments: Organizing for Uncertainty is a comprehensive report of research that addresses this important, rising issue. Authors Yvan Petit and Brian Hobbs present the results of their investigation in a report that significantly advances the theory and also offers tips for practice. Currently, those applying project portfolio management tend to focus on the selection, prioritization, and strategic alignment of projects. Little attention is afforded the potential disturbances to project portfolios such as new projects, terminated projects, delayed projects, incorrect planning due to high uncertainty, and changes in the external environment. Yet, these factors can have highly disruptive, even show-stopping influence. This research seeks to answer: How is uncertainty affecting project portfolios managed in dynamic environments?

Download or read book Product Lifecycle Management Leveraging Digital Twins Circular Economy and Knowledge Management for Sustainable Innovation written by Christophe Danjou and published by Springer Nature. This book was released on with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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