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Author :
Publisher : Global Regulatory Press
ISBN 13 : 1903757010
Total Pages : 8 pages
Book Rating : 4.9/5 (37 download)
Download or read book Medical Device Regulations in Asia, Africa and the Middle East, written by and published by Global Regulatory Press. This book was released on with total page 8 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 0429996772
Total Pages : 620 pages
Book Rating : 4.4/5 (299 download)
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2018-03-28 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Author : Jack Wong
Publisher : Jenny Stanford Publishing
ISBN 13 : 9789814774314
Total Pages : 620 pages
Book Rating : 4.7/5 (743 download)
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by Jenny Stanford Publishing. This book was released on 2018-03-21 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 9814411213
Total Pages : 618 pages
Book Rating : 4.8/5 (144 download)
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2013-03-27 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.
Author : Almir Badnjević
Publisher : Springer Nature
ISBN 13 : 3031434447
Total Pages : 441 pages
Book Rating : 4.0/5 (314 download)
Download or read book Inspection of Medical Devices written by Almir Badnjević and published by Springer Nature. This book was released on 2023-12-28 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241564040
Total Pages : 147 pages
Book Rating : 4.2/5 (415 download)
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Author : Elijah Wreh
Publisher : Elsevier
ISBN 13 : 0323953530
Total Pages : 680 pages
Book Rating : 4.3/5 (239 download)
Download or read book Medical Device Regulation written by Elijah Wreh and published by Elsevier. This book was released on 2023-02-22 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations
Author : National Intelligence Council
Publisher : Cosimo Reports
ISBN 13 : 9781646794973
Total Pages : 158 pages
Book Rating : 4.7/5 (949 download)
Download or read book Global Trends 2040 written by National Intelligence Council and published by Cosimo Reports. This book was released on 2021-03 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The ongoing COVID-19 pandemic marks the most significant, singular global disruption since World War II, with health, economic, political, and security implications that will ripple for years to come." -Global Trends 2040 (2021) Global Trends 2040-A More Contested World (2021), released by the US National Intelligence Council, is the latest report in its series of reports starting in 1997 about megatrends and the world's future. This report, strongly influenced by the COVID-19 pandemic, paints a bleak picture of the future and describes a contested, fragmented and turbulent world. It specifically discusses the four main trends that will shape tomorrow's world: - Demographics-by 2040, 1.4 billion people will be added mostly in Africa and South Asia. - Economics-increased government debt and concentrated economic power will escalate problems for the poor and middleclass. - Climate-a hotter world will increase water, food, and health insecurity. - Technology-the emergence of new technologies could both solve and cause problems for human life. Students of trends, policymakers, entrepreneurs, academics, journalists and anyone eager for a glimpse into the next decades, will find this report, with colored graphs, essential reading.
Author : William I. White
Publisher : Taylor & Francis
ISBN 13 : 1351032569
Total Pages : 222 pages
Book Rating : 4.3/5 (51 download)
Download or read book Excellence Beyond Compliance written by William I. White and published by Taylor & Francis. This book was released on 2018-05-16 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation. This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful. After a review of the challenges that any medical device company faces in the world of today—the multiple sources of QMS requirements—the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help. This book offers: Advice that will lead to an effective and efficient QMS. Detailed guidance on the key decisions to be made regarding the quality system being established. Detailed ideas on how to execute those decisions. Up-to-date information on compliance to current regulations and standards and guidance on staying up to date. Specific examples of procedures. Information regarding requirements for combination products, such as a drug + device combination. Advice on incorporating risk management in the QMS.
Author : World Intellectual Property Organization
Publisher : WIPO
ISBN 13 : 9280523082
Total Pages : 259 pages
Book Rating : 4.2/5 (85 download)
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Author : Susan Neadle
Publisher : CRC Press
ISBN 13 : 1000874583
Total Pages : 439 pages
Book Rating : 4.0/5 (8 download)
Download or read book The Combination Products Handbook written by Susan Neadle and published by CRC Press. This book was released on 2023-05-16 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Seshadri Neervannan
Publisher : Springer Nature
ISBN 13 : 3030763676
Total Pages : 650 pages
Book Rating : 4.0/5 (37 download)
Download or read book Ophthalmic Product Development written by Seshadri Neervannan and published by Springer Nature. This book was released on 2022-03-11 with total page 650 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive textbook addressing the unique aspects of drug development for ophthalmic use. Beginning with a perspective on anatomy and physiology of the eye, the book provides a critical appraisal of principles that underlie ocular drug product development. The coverage encompasses topical and intraocular formulations, small molecules and biologics (including protein and gene therapies), conventional formulations (including solutions, suspensions, and emulsions), novel formulations (including nanoparticles, microparticles, and hydrogels), devices, and specialty products. Critical elements such as pharmacokinetics, influence of formulation technologies and ingredients, as well as impact of disease conditions on products development are addressed. Products intended for both the front and the back of the eye are discussed with an eye towards future advances. @font-face {font-family:"Cambria Math"; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:roman; mso-font-pitch:variable; mso-font-signature:3 0 0 0 1 0;}@font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-469750017 -1073732485 9 0 511 0;}p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0cm; mso-pagination:widow-orphan; font-size:12.0pt; font-family:"Times New Roman",serif; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}.MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:"Calibri",sans-serif; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}div.WordSection1 {page:WordSection1;}
Author : Damianos P. Sakas
Publisher : Springer
ISBN 13 : 3030160998
Total Pages : 275 pages
Book Rating : 4.0/5 (31 download)
Download or read book Strategic Innovative Marketing written by Damianos P. Sakas and published by Springer. This book was released on 2019-05-25 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: This proceedings volume highlights cutting-edge approaches for contemporary issues evolved in strategic marketing and the integration of theory and practice. It focuses on strategic research and innovative activities in marketing that can be used in everyday operations. The contributions have been divided into eight sections, grouping emerging marketing technologies together in a close examination of practices, problems and trends. The first section examines management challenges which influence societies, cultures, networks, organizations, teams, and individuals. It emphasizes ways business processes foster innovation and facilitate management transitions from dominant structures to more evolutionary, developmental paradigms. The second section discusses the benefits and guidelines to implementation of green marketing strategies. The following section pursues new perspectives of the role of location in marketing and its impact on consumer well-being. The next section explores the impacts of user generated content (UGC) on marketing theories and practice, which is followed by a section identifying how market-based assets can contribute to a sustainable competitive advantage. The sixth section covers understanding consumer perception to make marketing decisions. The final sections promote the use of business informatics and modeling in marketing and also the development of integrating information management in ways that change how people use information to engage in knowledge focused activities. The papers from the proceedings of the 6th International Conference on Strategic Innovative Marketing (IC-SIM 2017) have been written by scientists, researchers, practitioners and students that demonstrate a special orientation in strategic marketing, all of whom aspire to be ahead of the curve based on the pillars of innovation. This proceedings volume shares their recent contributions to the field and showcases their exchange of insights on strategic issues in the science of innovation marketing.
Author : Centers for Disease Control and Prevention CDC
Publisher : Oxford University Press
ISBN 13 : 0190628634
Total Pages : 705 pages
Book Rating : 4.1/5 (96 download)
Download or read book CDC Yellow Book 2018: Health Information for International Travel written by Centers for Disease Control and Prevention CDC and published by Oxford University Press. This book was released on 2017-04-17 with total page 705 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.
Author : United States. Congress. Senate. Committee on Labor and Public Welfare
Publisher :
ISBN 13 :
Total Pages : 250 pages
Book Rating : 4.F/5 ( download)
Download or read book International Health and Medical Research Act of 1959 written by United States. Congress. Senate. Committee on Labor and Public Welfare and published by . This book was released on 1959 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Vandana Patravale
Publisher : Elsevier
ISBN 13 : 0323954979
Total Pages : 482 pages
Book Rating : 4.3/5 (239 download)
Download or read book Polymers for Pharmaceutical and Biomedical Applications written by Vandana Patravale and published by Elsevier. This book was released on 2024-01-16 with total page 482 pages. Available in PDF, EPUB and Kindle. Book excerpt: Polymers for Pharmaceutical and Biomedical Applications: Fundamentals, Selection, and Preparation supports the successful selection, design, and development of polymers with the required properties and performance for a range of advanced pharmaceutical and biomedical applications. The book begins by introducing polymers for pharmaceutical and biomedical applications, examining classification, basic properties, structures, and grades. This is followed by in-depth chapters focusing on synthesis and modification, characterization techniques, and dissolution and solubility of polymers for pharmaceutical applications. Key applications are then highlighted, with chapters explaining in detail the preparation of polymers for conventional dosage, modified drug delivery, conjugates, advanced drug and gene delivery, medical devices, pharmaceutical packaging, tissue engineering, artificial organs, and dentistry. Throughout the book, the aim is to provide accessible, step-by-step coverage, supported by diagrams and case studies. Finally, safety and regulatory aspects are discussed. This is a valuable resource for all those who are newly approaching the field of polymers and product development for pharmaceutical and biomedical applications. This includes researchers and advanced students across polymer science, pharmaceutical science, biomaterials, biomedicine, healthcare, and chemistry, and scientists and R&D professionals in an industrial setting. Explains fundamental concepts relating to the synthesis, modification, and characterization of polymers Guides the reader towards successful selection of polymer systems for specific target applications Addresses key challenges in this field that are supported by case studies and regulatory information
Author : Kingston Rajiah
Publisher : Frontiers Media SA
ISBN 13 : 2889763021
Total Pages : 200 pages
Book Rating : 4.8/5 (897 download)
Download or read book Social and Administrative Policy in Healthcare and Pharmacy Practice written by Kingston Rajiah and published by Frontiers Media SA. This book was released on 2022-06-01 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt:
