Want To Get To Grips With US Regulatory Affairs for Medical Devices?
Thursday 20th June 2019
This essential course will provide you with a comprehensive foundation in US regulatory affairs to make your submission a success. Delegates will gain a solid understanding of regulatory standards, requirements and submission options and processes, including current hot topics such as software as a medical device.
This one day training course is designed to help you:
- Understand the scope of FDA regulation
- Consider the possible approval routes
- Investigate how devices are reviewed by the FDA
- Examine labeling and UDI requirements
- Learn where to find the information you need