Handbook of Medical Device Regulatory Affairs in Asia: Second Edition
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.
yazar | Jenny Stanford Publishing; 2. baskı |
---|---|
Boyutlar ve boyutlar | 15,2 x 3,5 x 22,9 cm |
Tarafından yayınlandı | 21 Mart 2018 |
Mdpi AG 18,9 x 0,4 x 24,6 cm Additional Contributors 18,9 x 0,3 x 24,6 cm 28 Ekim 2011 18,9 x 0,6 x 24,6 cm 28 Şubat 2018 ROBERT H BORK Kolektif 18,9 x 0,2 x 24,6 cm 3 Ocak 2017 WADE H MCCREE 15 x 0,5 x 22 cm 30 Ekim 2011 18,9 x 0,5 x 24,6 cm 29 Ekim 2011 ERWIN N GRISWOLD 1 Ocak 2017
okumak okumak kayıt olmadan
Sürüm ayrıntıları
yazar | Jenny Stanford Publishing; 2. baskı |
---|---|
isbn 10 | 9814774316 |
isbn 13 | 978-9814774314 |
Yayımcı | Jenny Stanford Publishing; 2. baskı |
Dilim | İngilizce |
Boyutlar ve boyutlar | 15,2 x 3,5 x 22,9 cm |
Tarafından yayınlandı Handbook of Medical Device Regulatory Affairs in Asia: Second Edition | 21 Mart 2018 |
En son kitaplar
benzer kitaplar
Econometric Model Specification: Consistent Model Specification Tests and Semi-Nonparametric Modeling and Inference
okumak kayıt olmadan
Reason, Thought and Language or the Many and the One, a: Revised System of Logical Doctrine in Relation to the Forms of Idiomatic Discourse (Classic Reprint)
okumak kayıt olmadan
Code of Federal Regulations, Title 12 Banks and Banking 200-219, Revised as of January 1, 2020
okumak kayıt olmadan
Econometric Model Specification: Consistent Model Specification Tests and Semi-Nonparametric Modeling and Inference
okumak kayıt olmadan
Reason, Thought and Language or the Many and the One, a: Revised System of Logical Doctrine in Relation to the Forms of Idiomatic Discourse (Classic Reprint)
okumak kayıt olmadan
Code of Federal Regulations, Title 12 Banks and Banking 200-219, Revised as of January 1, 2020
okumak kayıt olmadan