Evolution De Liso 13485 2016

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Handbook of Biomarkers and Precision Medicine

Author : Claudio Carini
Publisher : CRC Press
ISBN 13 : 0429574622
Total Pages : 953 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Handbook of Biomarkers and Precision Medicine by : Claudio Carini

Download or read book Handbook of Biomarkers and Precision Medicine written by Claudio Carini and published by CRC Press. This book was released on 2019-04-16 with total page 953 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

Quality Risk Management in the FDA-Regulated Industry

Author : José Rodríguez-Pérez
Publisher : Quality Press
ISBN 13 : 1953079326
Total Pages : 252 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez-Pérez

Download or read book Quality Risk Management in the FDA-Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.

Service Design for Emerging Technologies Product Development

Author : Umar Zakir Abdul Hamid
Publisher : Springer Nature
ISBN 13 : 3031293061
Total Pages : 336 pages
Book Rating : 4.0/5 (312 download)

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Book Synopsis Service Design for Emerging Technologies Product Development by : Umar Zakir Abdul Hamid

Download or read book Service Design for Emerging Technologies Product Development written by Umar Zakir Abdul Hamid and published by Springer Nature. This book was released on 2023-07-20 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: The productization of emerging technologies related to the Fourth Industrial Revolution (FIR) is now getting more attention across different industries. Compared to the previous industrial transformations that the world has seen which relied on mechanical innovations, the ongoing FIR is seeing software and data-driven products as the foundation. Apart from that, topics such as circular and sustainable economy as well as climate change are also disrupting the industrial ecosystem. For a viable and successful productization of emerging technologies, collaborations between interdisciplinary stakeholders are a necessity. One of the elements that has been identified to facilitate this collaboration is service design. This book aimed to provide comprehensive service design discussions for practitioners in different fields and sectors. The aim is to bridge the knowledge gap between experts in academia, business and product development, among many others, to provide a unified understanding of the importance of service design for the productization of emerging technologies. The book consists of an overview of emerging technologies product development and service design, as well as perspectives from different sectors of the industry. The book is expected to benefit multi-disciplinary researchers, practitioners and general audiences with interests in Service Design for Emerging Technologies.

Comparative handbook: robotic technologies law

Author : Alain Bensoussan
Publisher : Éditions Larcier
ISBN 13 : 2804491773
Total Pages : 295 pages
Book Rating : 4.8/5 (44 download)

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Book Synopsis Comparative handbook: robotic technologies law by : Alain Bensoussan

Download or read book Comparative handbook: robotic technologies law written by Alain Bensoussan and published by Éditions Larcier. This book was released on 2016-06-28 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: Studies of the overall impact of robotics on the economy have shown that investments in its various sectors – industrial, professional and service robotics – are increasing globally and the markets associated with them are valued in billions. Robotization improves the competitiveness of enterprises, while collaborative robotics reinvents methods of production. Beyond the economic outlook, service robotics, backed by the development of artificial intelligence, raises challenging ethical and social issues. The legal analysis of robotics is no mean feat because it covers a very diverse technical reality. Companies whose businesses are focused on robotic technologies and applications can be confronted with a complex legal situation resulting from the plurality of the applicable rules which have not necessarily been conceived or adopted bearing in mind their specific constraints. This situation should not hamper their development. It only implies taking cues from the economic legal norms which promote such developments and conducting an analysis of the legal risks which they face, given the applicable rules of liability. This comparative study – carried out by members of the Lexing® Network – proposes an overview, having regard to the legislation of 17 different countries, of the legal issues raised by robotics and the way the law in force responds, in a more or less satisfactory manner. Discover the authors & contributors in details under the tab 'Extraits'.

Managing Software Process Evolution

Author : Marco Kuhrmann
Publisher : Springer
ISBN 13 : 3319315455
Total Pages : 345 pages
Book Rating : 4.3/5 (193 download)

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Book Synopsis Managing Software Process Evolution by : Marco Kuhrmann

Download or read book Managing Software Process Evolution written by Marco Kuhrmann and published by Springer. This book was released on 2016-09-15 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the design, development, management, governance and application of evolving software processes that are aligned with changing business objectives, such as expansion to new domains or shifting to global production. In the context of an evolving business world, it examines the complete software process lifecycle, from the initial definition of a product to its systematic improvement. In doing so, it addresses difficult problems, such as how to implement processes in highly regulated domains or where to find a suitable notation system for documenting processes, and provides essential insights and tips to help readers manage process evolutions. And last but not least, it provides a wealth of examples and cases on how to deal with software evolution in practice. Reflecting these topics, the book is divided into three parts. Part 1 focuses on software business transformation and addresses the questions of which process(es) to use and adapt, and how to organize process improvement programs. Subsequently, Part 2 mainly addresses process modeling. Lastly, Part 3 collects concrete approaches, experiences, and recommendations that can help to improve software processes, with a particular focus on specific lifecycle phases. This book is aimed at anyone interested in understanding and optimizing software development tasks at their organization. While the experiences and ideas presented will be useful for both those readers who are unfamiliar with software process improvement and want to get an overview of the different aspects of the topic, and for those who are experts with many years of experience, it particularly targets the needs of researchers and Ph.D. students in the area of software and systems engineering or information systems who study advanced topics concerning the organization and management of (software development) projects and process improvements projects.

Hearing Health Care for Adults

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309439264
Total Pages : 325 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Hearing Health Care for Adults by : National Academies of Sciences, Engineering, and Medicine

Download or read book Hearing Health Care for Adults written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-10-06 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: The loss of hearing - be it gradual or acute, mild or severe, present since birth or acquired in older age - can have significant effects on one's communication abilities, quality of life, social participation, and health. Despite this, many people with hearing loss do not seek or receive hearing health care. The reasons are numerous, complex, and often interconnected. For some, hearing health care is not affordable. For others, the appropriate services are difficult to access, or individuals do not know how or where to access them. Others may not want to deal with the stigma that they and society may associate with needing hearing health care and obtaining that care. Still others do not recognize they need hearing health care, as hearing loss is an invisible health condition that often worsens gradually over time. In the United States, an estimated 30 million individuals (12.7 percent of Americans ages 12 years or older) have hearing loss. Globally, hearing loss has been identified as the fifth leading cause of years lived with disability. Successful hearing health care enables individuals with hearing loss to have the freedom to communicate in their environments in ways that are culturally appropriate and that preserve their dignity and function. Hearing Health Care for Adults focuses on improving the accessibility and affordability of hearing health care for adults of all ages. This study examines the hearing health care system, with a focus on non-surgical technologies and services, and offers recommendations for improving access to, the affordability of, and the quality of hearing health care for adults of all ages.

Ensuring Quality to Gain Access to Global Markets

Author : Martin Kellermann
Publisher : World Bank Publications
ISBN 13 : 1464813728
Total Pages : 275 pages
Book Rating : 4.4/5 (648 download)

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Book Synopsis Ensuring Quality to Gain Access to Global Markets by : Martin Kellermann

Download or read book Ensuring Quality to Gain Access to Global Markets written by Martin Kellermann and published by World Bank Publications. This book was released on 2019-04-09 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a modern world with rapidly growing international trade, countries compete less based on the availability of natural resources, geographical advantages, and lower labor costs and more on factors related to firms' ability to enter and compete in new markets. One such factor is the ability to demonstrate the quality and safety of goods and services expected by consumers and confirm compliance with international standards. To assure such compliance, a sound quality infrastructure (QI) ecosystem is essential. Jointly developed by the World Bank Group and the National Metrology Institute of Germany, this guide is designed to help development partners and governments analyze a country's quality infrastructure ecosystems and provide recommendations to design and implement reforms and enhance the capacity of their QI institutions.

Medical Device Design

Author :
Publisher : Academic Press
ISBN 13 : 0123919436
Total Pages : 369 pages
Book Rating : 4.1/5 (239 download)

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Book Synopsis Medical Device Design by :

Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Integrated Management Systems

Author :
Publisher :
ISBN 13 : 9780857246332
Total Pages : 0 pages
Book Rating : 4.2/5 (463 download)

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Book Synopsis Integrated Management Systems by :

Download or read book Integrated Management Systems written by and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Lateral Flow Immunoassay

Author : Raphael Wong
Publisher : Springer Science & Business Media
ISBN 13 : 1597452408
Total Pages : 224 pages
Book Rating : 4.5/5 (974 download)

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Book Synopsis Lateral Flow Immunoassay by : Raphael Wong

Download or read book Lateral Flow Immunoassay written by Raphael Wong and published by Springer Science & Business Media. This book was released on 2008-12-16 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to the simplicity, relative accuracy, fast result reporting, and user-friendliness of lateral flow immunoassay, its use has undergone tremendous growth in the diagnostic industry in the last few years. Such technology has been utilized widely and includes pregnancy and woman's health determination, cardiac and emergency conditions monitoring and testing, infectious disease including Flu screening, cancer marker screening, and drugs abuse testing. This book covers the scope of utilization, the principle of the technology, the patent concerns, information on the development and production of the test device and specific applications will be of interest to the diagnostic industry and the general scientific community.

The 'Made in Germany' Champion Brands

Author : Ugesh A. Joseph
Publisher : Routledge
ISBN 13 : 1317025032
Total Pages : 296 pages
Book Rating : 4.3/5 (17 download)

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Book Synopsis The 'Made in Germany' Champion Brands by : Ugesh A. Joseph

Download or read book The 'Made in Germany' Champion Brands written by Ugesh A. Joseph and published by Routledge. This book was released on 2016-03-09 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Germany’s economic miracle is a widely-known phenomenon, and the world-leading, innovative products and services associated with German companies are something that others seek to imitate. In The ’Made in Germany’Â’ Champion Brands, Ugesh A. Joseph provides an extensively researched, insightful look at over 200 of Germany’s best brands to see what they stand for, what has made them what they are today, and what might be transferable. The way Germany is branded as a nation carries across into the branding of its companies and services, particularly the global superstar brands - truly world-class in size, performance and reputation. Just as important are the medium-sized and small enterprises, known as the 'Mittelstand'. These innovative and successful enterprises from a wide range of industries and product / service categories are amongst the World market leaders in their own niche and play a huge part in making Germany what it is today. The book also focuses on German industrial entrepreneurship and a selection of innovative and emergent stars. All these companies are supported and encouraged by a sophisticated infrastructure of facilitators, influencers and enhancers - the research, industry, trade and standards organizations, the fairs and exhibitions and all the social and cultural factors that influence, enhance and add positive value to the country's image. Professionals or academics interested in business; entrepreneurship; branding and marketing; product or service development; international trade and business development policy, will find fascinating insights in this book; while those with an interest in Germany from emerging industrial economies will learn something of the secrets of German success.

Spacesuit

Author : Nicholas De Monchaux
Publisher : MIT Press
ISBN 13 : 026201520X
Total Pages : 379 pages
Book Rating : 4.2/5 (62 download)

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Book Synopsis Spacesuit by : Nicholas De Monchaux

Download or read book Spacesuit written by Nicholas De Monchaux and published by MIT Press. This book was released on 2011-03-18 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: How the twenty-one-layer Apollo spacesuit, made by Playtex, was a triumph of intimacy over engineering. When Neil Armstrong and Buzz Aldrin stepped onto the lunar surface in July of 1969, they wore spacesuits made by Playtex: twenty-one layers of fabric, each with a distinct yet interrelated function, custom-sewn for them by seamstresses whose usual work was fashioning bras and girdles. This book is the story of that spacesuit. It is a story of the triumph over the military-industrial complex by the International Latex Corporation, best known by its consumer brand of "Playtex"—a victory of elegant softness over engineered hardness, of adaptation over cybernetics. Playtex's spacesuit went up against hard armor-like spacesuits designed by military contractors and favored by NASA's engineers. It was only when those attempts failed—when traditional engineering firms could not integrate the body into mission requirements—that Playtex, with its intimate expertise, got the job. In Spacesuit, Nicholas de Monchaux tells the story of the twenty-one-layer spacesuit in twenty-one chapters addressing twenty-one topics relevant to the suit, the body, and the technology of the twentieth century. He touches, among other things, on eighteenth-century androids, Christian Dior's New Look, Atlas missiles, cybernetics and cyborgs, latex, JFK's carefully cultivated image, the CBS lunar broadcast soundstage, NASA's Mission Control, and the applications of Apollo-style engineering to city planning. The twenty-one-layer spacesuit, de Monchaux argues, offers an object lesson. It tells us about redundancy and interdependence and about the distinctions between natural and man-made complexity; it teaches us to know the virtues of adaptation and to see the future as a set of possibilities rather than a scripted scenario.

Advances in Human Factors, Business Management and Leadership

Author : Jussi Ilari Kantola
Publisher : Springer Nature
ISBN 13 : 3030507912
Total Pages : 654 pages
Book Rating : 4.0/5 (35 download)

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Book Synopsis Advances in Human Factors, Business Management and Leadership by : Jussi Ilari Kantola

Download or read book Advances in Human Factors, Business Management and Leadership written by Jussi Ilari Kantola and published by Springer Nature. This book was released on 2020-06-30 with total page 654 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyzes new theories and practical approaches for promoting excellence in human resource management and leadership. It shows how the principles of creating shared value can be applied to ensure faster learning, training, business development and social renewal. In particular, it presents novel methods and tools for tackling the complexity of management and learning in both business organizations and society. Discussing ontologies, intelligent management systems, and methods for creating knowledge and value added, it offers novel insights into time management and operations optimization, as well as advanced methods for evaluating customers’ satisfaction and conscious experience. Based on two AHFE 2020 Virtual Conferences: the AHFE 2020 Conference on Human Factors, Business Management and Society and the AHFE 2020 Conference on Human Factors in Management and Leadership, held on July 16–20, 2020, the book provides researchers and professionals with extensive information, practical tools and inspiring ideas for achieving excellence in a broad spectrum of business and societal activities.

Epigenetic Biomarkers and Diagnostics

Author : Jose Luis Garcia-Gimenez
Publisher : Academic Press
ISBN 13 : 0128019212
Total Pages : 698 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Epigenetic Biomarkers and Diagnostics by : Jose Luis Garcia-Gimenez

Download or read book Epigenetic Biomarkers and Diagnostics written by Jose Luis Garcia-Gimenez and published by Academic Press. This book was released on 2015-12-07 with total page 698 pages. Available in PDF, EPUB and Kindle. Book excerpt: Epigenetic Biomarkers and Diagnostics comprises 31 chapters contributed by leading active researchers in basic and clinical epigenetics. The book begins with the basis of epigenetic mechanisms and descriptions of epigenetic biomarkers that can be used in clinical diagnostics and prognostics. It goes on to discuss classical methods and next generation sequencing-based technologies to discover and analyze epigenetic biomarkers. The book concludes with an account of DNA methylation, post-translational modifications and noncoding RNAs as the most promising biomarkers for cancer (i.e. breast, lung, colon, etc.), metabolic disorders (i.e. diabetes and obesity), autoimmune diseases, infertility, allergy, infectious diseases, and neurological disorders. The book describes the challenging aspects of research in epigenetics, and current findings regarding new epigenetic elements and modifiers, providing guidance for researchers interested in the most advanced technologies and tested biomarkers to be used in the clinical diagnosis or prognosis of disease. - Focuses on recent progress in several areas of epigenetics, general concepts regarding epigenetics, and the future prospects of this discipline in clinical diagnostics and prognostics - Describes the importance of the quality of samples and clinical associated data, and also the ethical issues for epigenetic diagnostics - Discusses the advances in epigenomics technologies, including next-generation sequencing based tools and applications - Expounds on the utility of epigenetic biomarkers for diagnosis and prognosis of several diseases, highlighting the study of these biomarkers in cancer, cardiovascular and metabolic diseases, infertility, and infectious diseases - Includes a special section that discusses the relevance of biobanks in the maintenance of high quality biosamples and clinical-associated data, and the relevance of the ethical aspects in epigenetic studies

Kazakhstan: Accelerating Economic Diversification

Author : Kym Anderson
Publisher : Asian Development Bank
ISBN 13 : 9292612638
Total Pages : 219 pages
Book Rating : 4.2/5 (926 download)

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Book Synopsis Kazakhstan: Accelerating Economic Diversification by : Kym Anderson

Download or read book Kazakhstan: Accelerating Economic Diversification written by Kym Anderson and published by Asian Development Bank. This book was released on 2018-08-01 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: Kazakhstan has the potential to become an economic leader in Central Asia. Relying on oil and gas alone, however, will not produce the long-run level of growth needed to meet this potential. Reforms geared to improve the business climate, enhance competitiveness, and increase private sector participation are essential. This book examines reforms to accelerate economic diversification in the country. This involves not only modernizing and using public resources in agriculture more efficiently to increase productivity, but also transitioning of manufacturing toward high-potential exports to help the country’s industrial development and create employment opportunities. Upgrading innovation of oilfield services and improving transport and logistics are important to increase participation in the global value chains.

ISO 9001, ISO 14001, and New Management Standards

Author : Iñaki Heras-Saizarbitoria
Publisher : Springer
ISBN 13 : 3319656759
Total Pages : 218 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis ISO 9001, ISO 14001, and New Management Standards by : Iñaki Heras-Saizarbitoria

Download or read book ISO 9001, ISO 14001, and New Management Standards written by Iñaki Heras-Saizarbitoria and published by Springer. This book was released on 2017-10-10 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a comprehensive reference on ISO management system standards and their implementation. The impacts that ISO 9001 and ISO 14001 have had on business performance are analyzed in depth, and up-to-date perspectives are offered on the integration of these and other management standards (e.g. SA8000, ISO/TS 16949). Detailed information is provided on the signaling value of different management standards and on the new ISO standards for management systems, such as ISO 50001 and ISO 45001, relating to energy management and occupational health and safety. The role of audits in ensuring compliance with the standards and achievement of objectives is also carefully considered. The volume examines avenues for further research and emerging challenges. In offering an integrated, holistic perspective on ISO management system standards, this book will have wide appeal for academics, public decision-makers, and practitioners in the field of quality and environmental management.

Introduction to Medical Software

Author : Xenophon Papademetris
Publisher : Cambridge University Press
ISBN 13 : 1316514994
Total Pages : 341 pages
Book Rating : 4.3/5 (165 download)

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Book Synopsis Introduction to Medical Software by : Xenophon Papademetris

Download or read book Introduction to Medical Software written by Xenophon Papademetris and published by Cambridge University Press. This book was released on 2022-05-05 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise and accessible overview of the design, implementation and management of medical software.