IEC 62304 A Complete Guide - 2020 Edition.

How do you produce usable, medical device regulated software? Does your organization have a product security function? Software cannot be released for use until validation has been completed? How frequent are computing technology-related medical device failures? Who is responsible for on-line help? This breakthrough IEC 62304 self-assessment will make you the reliable IEC 62304 domain authority by revealing just what you need to know to be fluent and ready for any IEC 62304 challenge. How do I reduce the effort in the IEC 62304 work to be done to get problems solved? How can I ensure that plans of action include every IEC 62304 task and that every IEC 62304 outcome is in place? How will I save time investigating strategic and tactical options and ensuring IEC 62304 costs are low? How can I deliver tailored IEC 62304 advice instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all IEC 62304 essentials are covered, from every angle: the IEC 62304 self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that IEC 62304 outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced IEC 62304 practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in IEC 62304 are maximized with professional results. Your purchase includes access details to the IEC 62304 self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific IEC 62304 Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. - Includes new coverage of ISO 14971:2019, ISO/TR 24971 - Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management - Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

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.

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."

This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house. It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations. This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice. Key Features: Up to date with the latest regulations in the UK, the EU, and the US Useful for those producing medical software for routine clinical use Contains best practice

SYSTEMS ENGINEERING HANDBOOK A comprehensive reference on the discipline and practice of systems engineering Systems engineering practitioners provide a wide range of vital functions, conceiving, developing, and supporting complex engineered systems with many interacting elements. The International Council on Systems Engineering (INCOSE) Systems Engineering Handbook describes the state-of-the-good-practice of systems engineering. The result is a comprehensive guide to systems engineering activities across any number of possible projects. From automotive to defense to healthcare to infrastructure, systems engineering practitioners are at the heart of any project built on complex systems. INCOSE Systems Engineering Handbook readers will find: Elaboration on the key systems life cycle processes described in ISO/IEC/IEEE 15288:2023; Chapters covering key systems engineering concepts, system life cycle processes and methods, tailoring and application considerations, systems engineering in practice, and more; and Appendices, including an N2 diagram of the systems engineering processes and a detailed topical index. The INCOSE Systems Engineering Handbook is a vital reference for systems engineering practitioners and engineers in other disciplines looking to perform or understand the discipline of systems engineering.

OpenVX is the computer vision API adopted by many high-performance processor vendors. It is quickly becoming the preferred way to write fast and power-efficient code on embedded systems. OpenVX Programming Guidebook presents definitive information on OpenVX 1.2 and 1.3, the Neural Network, and other extensions as well as the OpenVX Safety Critical standard. This book gives a high-level overview of the OpenVX standard, its design principles, and overall structure. It covers computer vision functions and the graph API, providing examples of usage for the majority of the functions. It is intended both for the first-time user of OpenVX and as a reference for experienced OpenVX developers. - Get to grips with the OpenVX standard and gain insight why various options were chosen - Start developing efficient OpenVX code instantly - Understand design principles and use them to create robust code - Develop consumer and industrial products that use computer vision to understand and interact with the real world

When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).