Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.

This handbook brings together diverse domains and technical competences of Model Based Systems Engineering (MBSE) into a single, comprehensive publication. It is intended for researchers, practitioners, and students/educators who require a wide-ranging and authoritative reference on MBSE with a multidisciplinary, global perspective. It is also meant for those who want to develop a sound understanding of the practice of systems engineering and MBSE, and/or who wish to teach both introductory and advanced graduate courses in systems engineering. It is specifically focused on individuals who want to understand what MBSE is, the deficiencies in current practice that MBSE overcomes, where and how it has been successfully applied, its benefits and payoffs, and how it is being deployed in different industries and across multiple applications. MBSE engineering practitioners and educators with expertise in different domains have contributed chapters that address various uses of MBSE and related technologies such as simulation and digital twin in the systems lifecycle. The introductory chapter reviews the current state of practice, discusses the genesis of MBSE and makes the business case. Subsequent chapters present the role of ontologies and meta-models in capturing system interdependencies, reasoning about system behavior with design and operational constraints; the use of formal modeling in system (model) verification and validation; ontology-enabled integration of systems and system-of-systems; digital twin-enabled model-based testing; system model design synthesis; model-based tradespace exploration; design for reuse; human-system integration; and role of simulation and Internet-of-Things (IoT) within MBSE.

This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization’s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors’ notes giving guidance derived from the authors’ sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.

Advances in Manufacturing and Processing of Materials and Structures cover the latest advances in materials and structures in manufacturing and processing including additive and subtractive processes. It's intended to provide a compiled resource that reviews details of the advances that have been made in recent years in manufacturing and processing of materials and structures. A key development incorporated within this book is 3D printing, which is being used to produce complex parts including composites with odd shape fibers, as well as tissue and body organs. This book has been tailored for engineers, scientists and practitioners in different fields such as aerospace, mechanical engineering, materials science and biomedicine. Biomimetic principles have also been integrated. Features Provides the latest state-of-the art on different manufacturing processes, including a biomimetics viewpoint Offers broad coverage of advances in materials and manufacturing Written by chapter authors who are world-class researchers in their respective fields Provides in-depth presentation of the latest 3D and 4D technologies related to various manufacturing disciplines Provides substantial references in each chapter to enhance further study

In order to improve competitiveness and performance, corporations must embrace advancements in digitalization. Successful implementation of knowledge management is a huge factor in corporate success. Analyzing the Impacts of Industry 4.0 in Modern Business Environments is a critical scholarly publication that explores digital transformation in business environments and the requirement for not only a substantial management change plan but equally the two essential components of knowledge management: knowledge sharing and knowledge transfer. Featuring a broad range of topics such as strategic planning, knowledge transfer, and cybersecurity risk management, this book is geared toward researchers, academicians, and students seeking current and relevant research on organizational knowledge intensity and monitoring of knowledge management development.

This book aims to give readers a basic understanding of commonly used additive manufacturing techniques as well as the tools to fully utilise the strengths of additive manufacturing through the modelling and design phase all the way through to post processing. Guidelines for 3D-printed biomedical implants are also provided. Current biomedical applications of 3D printing are discussed, including indirect applications in the rapid manufacture of prototype tooling and direct applications in the orthopaedics, cardiovascular, drug delivery, ear-nose-throat, and tissue engineering fields. Polymer-Based Additive Manufacturing: Biomedical Applications is an ideal resource for students, researchers, and those working in industry seeking to better understand the medical applications of additive manufacturing.

Computer Terminiologies - English

This book discusses the latest advances in digital modeling systems (DMSs) and additive manufacturing (AM) technologies. It covers applications of networked technologies, ubiquitous computing, new materials and hybrid production systems, discussing how they are changing the processes of conception, modeling and production of products and systems of product. The book emphasizes ergonomic and sustainability issues, as well as timely topics such as DMSs and AM in Industry 4.0, DMSs and AM in developing countries, DMSs and AM in extreme environments, thus highlighting future trends and promising scenarios for further developing those technologies. Based on the AHFE 2019 International Conference on Additive Manufacturing, Modeling Systems and 3D Prototyping, held on July 24-28, 2019, in Washington D.C., USA, the book is intended as source of inspiration for researchers, engineers and stakeholders, and to foster interdisciplinary and international collaborations between them.