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Handbook of Medical Device Regulatory Affairs in Asia Second Edition

Design Controls for the Medical Device Industry Third Edition

Design Controls for the Medical Device Industry Third Edition

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 | Design Controls for the Medical Device Industry Third Edition

GBP 150.00
1

ISO 13485:2016 A Complete Guide to Quality Management in the Medical Device Industry Second Edition

ISO 13485:2016 A Complete Guide to Quality Management in the Medical Device Industry Second Edition

Summary: This book provides valuable effective guidance for understanding interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself which enables easy navigation and orientation. Pragmatic in style and down to earth in tone this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems developing processes for design and development as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work. | ISO 13485:2016 A Complete Guide to Quality Management in the Medical Device Industry Second Edition

GBP 150.00
1

FinFET Devices for VLSI Circuits and Systems

Gallium Nitride Power Devices

An Introduction to Condensed Matter Physics for the Nanosciences

The Combination Products Handbook A Practical Guide for Combination Products and Other Combined Use Systems

The Combination Products Handbook A Practical Guide for Combination Products and Other Combined Use Systems

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. | The Combination Products Handbook A Practical Guide for Combination Products and Other Combined Use Systems

GBP 140.00
1

VLSI and Hardware Implementations using Modern Machine Learning Methods

Planar Antennas Design and Applications

Fabless Semiconductor Manufacturing In the Era of Internet of Things

Companion Diagnostics (CDx) in Precision Medicine

Bulk and Surface Acoustic Waves Fundamentals Devices and Applications

Introduction to Biomedical Engineering Technology 4th Edition Health Technology Management

Introduction to Biomedical Engineering Technology 4th Edition Health Technology Management

This updated fourth edition provides current information on devices and is divided into diagnostic and treatment sections. Devices are described with the theory of operation and relevant anatomical and physiological considerations. Aspects of BMET work including test equipment standards and information technology are also discussed. The text covers a wide variety of diagnostic and treatment devices currently used in hospitals that students will likely encounter in their career. Principles of operation and examples of use are provided. This book is unique in that it is written by an experienced biomed tech with 30 years’ experience in hospitals rather than by engineers with little frontline experience. It is also unique in that it provides ancillary materials on the web and is the only guide divided into diagnostic and treatment device sections. This new edition also includes two new chapters on computers information technology and networking as well as health technology management. From the previous edition: The book presents a comfortable balance between clinical applications basic technical information and various pictures of medical technologies one will encounter in the field. Additionally related anatomy and physiology principles and essential technical terms are a nice complement to the technologies presented. The everyday duties and responsibilities of a biomed are captured by the various ‘true-to-life’ scenarios introduced throughout the book. —Joey Jones Madisonville Community College Kentucky USA This book is intended for students in biomedical engineering technology and healthcare technology management (BMET/HTM) programs as well as biomedical engineering students. Field service representatives medical device designers and medical device sales representatives will also find it useful. | Introduction to Biomedical Engineering Technology 4th Edition Health Technology Management

GBP 115.00
1

Optical Parametric Generation and Amplification

Liberalism and Naval Strategy Ideology Interest and Sea Power During the Pax Britannica

Microstrip Antenna Design for Wireless Applications

Microstrip Antenna Design for Wireless Applications

This book focuses on recent advances in the field of microstrip antenna design and its applications in various fields including space communication mobile communication wireless communication medical implants and wearable applications. Scholars as well as researchers and those in the electronics/ electrical/ instrumentation engineering fields will benefit from this book. The book shall provides the necessary literature and techniques using which to assist students and researchers would design antennas for the above- mentioned applications and will ultimately enable users to take measurements in different environments. It is intended to help scholars and researchers in their studies by enhancing their the knowledge and skills in on the latest applications of microstrip antennas in the world of communications such as world like IoT D2D satellites and wearable devices to name a few. FEATURES Addresses the complete functional framework workflow in printed antenna design systems Explores the basic and high-level concepts including advanced aspects in planer design issues thus serving as a manual for those in the the industry while also assisting beginners Provides the latest techniques used for antennas in terms of structure defected ground MIMO and fractal designs Discusses case studies related to data-intensive technologies in microchip antennas in terms of the most recent applications and similar uses for the Internet of Things and device-to-device communication | Microstrip Antenna Design for Wireless Applications

GBP 115.00
1

ERGOCHECK for a Preliminary Mapping of Risk at Work Tools Guidelines and Applications

ERGOCHECK for a Preliminary Mapping of Risk at Work Tools Guidelines and Applications

One of the latest developments being pursued by the World Health Organization (WHO) and other international organizations (ILO ISO) in relation to preventing work-related diseases and disorders concerns the creation of toolkits and within them of simple tools. This book suggests a methodology and a comprehensive simple tool (ERGOCHECK downloadable for free from the website www. epmresearch. org) for bringing together various potential risk factors to undertake a preliminary mapping of discomfort/danger in the workplaces and to assess consequent priorities for prevention especially (but not only) in small and very small businesses. The tool is primarily designed to be used by employers OSH (Occupational Health and Safety) operators and trade union representatives but it may also be useful for occupational medical staff conducting periodical inspections and drafting health surveillance protocols and for supervisory bodies (labor inspectors) conducting inspections in the workplace needing to rapidly detect potentially dangerous situations requiring specific preventive interventions. Daniela Colombini is a certified European ergonomist and a senior researcher at the Research Unit Ergonomics of Posture and Movement Milan where she developed methods for the analysis evaluation and management of risk and damage from occupational biomechanical overload. She was a professor at the School of Specialization in Occupational Medicine in University of Milan and University of Florence. She is the coauthor of the OCRA method (EN 1005-5 standard and ISO 11228-3). She is the founder and president of the EPM International Ergonomics School (EPMIES). She has been working with accredited native teachers in countries such as the USA France India Spain Chile Colombia Guatemala Costa Rica Brazil and other South American countries. She is a member of the Ergonomics Committee of UNI working in the international commissions of European Committee for Normalization (CEN) and International Organization for Standardization (ISO). Enrico Occhipinti is a certified European ergonomist. He is a professor at the School of Specialization in Occupational Medicine in University of Milano and the director of the Research Unit Ergonomics of Posture and Movement (EPM) at Fondazione Don Gnocchi ONLUS-Milano. He developed and coauthored the OCRA method. He is a member and has been a coordinator (up to 2012) of the Technical Committee on Prevention of Musculoskeletal Disorders of the International Ergonomics Association (IEA) and represents Italy in international commissions of the CEN and the ISO dealing with ergonomics and biomechanics. | ERGOCHECK for a Preliminary Mapping of Risk at Work Tools Guidelines and Applications

GBP 105.00
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Handbook on Federated Learning Advances Applications and Opportunities

Handbook on Federated Learning Advances Applications and Opportunities

Mobile wearable and self-driving telephones are just a few examples of modern distributed networks that generate enormous amount of information every day. Due to the growing computing capacity of these devices as well as concerns over the transfer of private information it has become important to process the part of the data locally by moving the learning methods and computing to the border of devices. Federated learning has developed as a model of education in these situations. Federated learning (FL) is an expert form of decentralized machine learning (ML). It is essential in areas like privacy large-scale machine education and distribution. It is also based on the current stage of ICT and new hardware technology and is the next generation of artificial intelligence (AI). In FL central ML model is built with all the data available in a centralised environment in the traditional machine learning. It works without problems when the predictions can be served by a central server. Users require fast responses in mobile computing but the model processing happens at the sight of the server thus taking too long. The model can be placed in the end-user device but continuous learning is a challenge to overcome as models are programmed in a complete dataset and the end-user device lacks access to the entire data package. Another challenge with traditional machine learning is that user data is aggregated at a central location where it violates local privacy policies laws and make the data more vulnerable to data violation. This book provides a comprehensive approach in federated learning for various aspects. | Handbook on Federated Learning Advances Applications and Opportunities

GBP 120.00
1

Iran under Ahmadinejad The Politics of Confrontation

Vacuum and Ultravacuum Physics and Technology

Ideology and Rationality in the Soviet Model A legacy for Gorbachev

Lithium-Ion Batteries and Solar Cells Physical Chemical and Materials Properties

Transparent Semiconducting Oxides Bulk Crystal Growth and Fundamental Properties

Next Generation Wireless Terahertz Communication Networks

Nano-Interconnect Materials and Models for Next Generation Integrated Circuit Design