Kommande
bokomslag Medical Regulatory Affairs
Barnböcker

Medical Regulatory Affairs

Jack Wong Raymond Tong

Inbunden

3729:-

Funktionen begränsas av dina webbläsarinställningar (t.ex. privat läge).

Andra format:

  • 930 sidor
  • 2025
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. The updated fourth edition includes specific contributions that address the needs of startups.
  • Författare: Jack Wong, Raymond Tong
  • Format: Inbunden
  • ISBN: 9789815129595
  • Språk: Engelska
  • Antal sidor: 930
  • Utgivningsdatum: 2025-04-16
  • Förlag: Jenny Stanford Publishing