- We will send in 10–14 business days.
/images/books/13752585/9789814774314.jpg)
- Publisher: Jenny Stanford Publishing
- ISBN-10: 9814774316
- ISBN-13: 9789814774314
- Format: 15.2 x 22.9 x 3.5 cm, hardcover
- Language: English
- SAVE -10% with code: EXTRA
Handbook of Medical Device Regulatory Affairs in Asia (e-book) (used book) | bookbook.eu
Reviews
Description
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.
EXTRA 10 % discount with code: EXTRA
The promotion ends in 19d.12:44:02
The discount code is valid when purchasing from 10 €. Discounts do not stack.
- Publisher: Jenny Stanford Publishing
- ISBN-10: 9814774316
- ISBN-13: 9789814774314
- Format: 15.2 x 22.9 x 3.5 cm, hardcover
- Language: English English
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.
Reviews