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Medical Device Regulations: A Complete Guide 1st Edition – eBook PDF

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Medical Device Regulations: A Complete Guide – Ebook PDF

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Medical Device Regulations: A Complete Guide 1st Edition – Ebook PDF Instant Delivery – ISBN(s): 9780323911269,9780323911276,0323911269,0323911277

Product details:

  • ISBN-10 ‏ : ‎ 0323911277
  • ISBN-13 ‏ : ‎ 9780323911276
  • Author: Aakash Deep

Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety.

The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements.

Table contents:

Chapter 1. Introduction of medical devices
Chapter 2. Ethics of clinical trials of medical devices
Chapter 3. Regulations for medical devices in the United States
Chapter 4. Regulations of medical devices in Europe
Chapter 5. Regulations of medical devices in ASEAN countries
Chapter 6. Regulations of medical devices in Japan and China
Chapter 7. Regulations of medical devices in Canada
Chapter 8. Regulations of medical devices in India
Chapter 9. Regulations of medical devices in Australia
Chapter 10. Regulations of medical devices in Gulf Cooperation Council countries
Chapter 11. Regulations of medical devices in Sri Lanka
Chapter 12. Regulations of medical devices in Russia

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