Medical Device Regulations
A Complete Guide
- 1st Edition - January 13, 2022
- Latest edition
- Author: Aakash Deep
- Language: English
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 th… Read more
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Description
Description
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.
Key features
Key features
- Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries
- Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan)
- Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products
Readership
Readership
Medical device industries, clinical research organizations (CROs), ethics committees, regulatory authorities, international regulatory agencies and organizations, notified bodies and students and graduates in healthcare, Biomedical Engineers, Clinical Engineers, Policy Makers
Table of contents
Table of contents
2. Ethics of clinical trials of medical devices
3. Regulations for medical devices in the United States
4. Regulations of medical devices in Europe
5. Regulations of medical devices in ASEAN countries
6. Regulations of medical devices in Japan and China
7. Regulations of medical devices in Canada
8. Regulations of medical devices in India
9. Regulations of medical devices in Australia
10. Regulations of medical devices in GCC countries
11. Regulations of medical devices in Sri Lanka
12. Regulations of medical devices in Russia
Product details
Product details
- Edition: 1
- Latest edition
- Published: January 13, 2022
- Language: English
About the author
About the author
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