Gebundenes Buch

Handbook of Medical Device Regulatory Affairs in Asia

Second Edition

Herausgeber: Wong, Jack; Tong, Raymond K. Y.

Beschreibung

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.

Autor

Jack Wong is regulatory affairs head, Asia Pacific, at Baxter Healthcare. He has more than 20 years of experience in regulatory affairs, clinical trials, and pharmacovigilance in Asia with good knowledge in the field of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products. Raymond Tong is professor and founding chair in the Department of Biomedical Engineering, the Chinese University of Hong Kong; chair, the Hong Kong Local Responsible Person Panel; chair of the Asia Regulatory Professional Association (ARPA)-Hong Kong Academy; and honorary advisor of the Hong Kong Medical and Healthcare Device Industries Association.

Produktdetails

• Verlag: Jenny Stanford Publishing
• 2. Auflage
• Seitenzahl: 656
• Erscheinungstermin: 20. April 2018
• Englisch
• Abmessung: 235mm x 157mm x 39mm
• Gewicht: 1086g
• ISBN-13: 9789814774314
• ISBN-10: 9814774316
• Artikelnr.: 52459596