Fundamentals Of Medical Device Regulations Fourth Edition
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Fundamentals of Medical Device Regulations Fourth Edition
![Fundamentals of Medical Device Regulations Fourth Edition](https://youbookinc.com/wp-content/uploads/2024/06/cover.jpg)
Author | : Gloria Hall |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2021-07-23 |
Genre | : Electronic Book |
ISBN | : 1947493671 |
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Fundamentals of Medical Device Regulations Third Edition
Author | : Gloria Hall,Pamela Anne Jones |
Publsiher | : Unknown |
Total Pages | : 726 |
Release | : 2020-07-29 |
Genre | : Medical instruments and apparatus |
ISBN | : 1947493493 |
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Fundamentals of Medical Device Regulations is a compilation of history, medical device and in vitro diagnotic (IVD) medical device information from RAPS' regional publications: Fundamentals of US Regulatory Affairs, Eleventh Edition; Fundamentals of Canadian Medical Device Regulations; Fundamentals of EU Regulatory Affairs, Ninth Edition; Fundamentals of International Regulatory Affairs, Fourth Edition."--Foreword.
Fundamentals of Medical Device Regulations
![Fundamentals of Medical Device Regulations](https://youbookinc.com/wp-content/uploads/2024/06/cover.jpg)
Author | : Pamela A. Jones |
Publsiher | : Unknown |
Total Pages | : 672 |
Release | : 2019 |
Genre | : Medical instruments and apparatus |
ISBN | : 194749337X |
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Fundamentals of Medical Device Regulations Fifth Edition
![Fundamentals of Medical Device Regulations Fifth Edition](https://youbookinc.com/wp-content/uploads/2024/06/cover.jpg)
Author | : Gloria Hall |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2022-05-20 |
Genre | : Electronic Book |
ISBN | : 1947493795 |
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Fundamentals of International Medical Device Regulations
![Fundamentals of International Medical Device Regulations](https://youbookinc.com/wp-content/uploads/2024/06/cover.jpg)
Author | : Zeeshaan Arshad,Gert Bos,David Brindley,Elizabeth Goldstein,Xiaoli Gou,Celine-Lea Halioua-Haubold,Jocelyn Jennings,Evangeline Loh,James Smith |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2017 |
Genre | : Electronic Book |
ISBN | : 0997769718 |
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Global Medical Device Regulation Second Edition
![Global Medical Device Regulation Second Edition](https://youbookinc.com/wp-content/uploads/2024/06/cover.jpg)
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2014-02-15 |
Genre | : Electronic Book |
ISBN | : 0989802841 |
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Compilation of medical device chapters from RAPS' Fundamentals of Regulatory Affairs series.
Handbook of Medical Device Regulatory Affairs in Asia
Author | : Jack Wong,Raymond Tong |
Publsiher | : CRC Press |
Total Pages | : 494 |
Release | : 2018-03-28 |
Genre | : Medical |
ISBN | : 9780429996764 |
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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.
Medical Regulatory Affairs
Author | : Jack Wong,Raymond K. Y. Tong |
Publsiher | : CRC Press |
Total Pages | : 806 |
Release | : 2022-01-27 |
Genre | : Medical |
ISBN | : 9781000440515 |
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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. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.