The US is a huge market for medical devices, yet there are a number of key differences between FDA procedures and those in Europe.
This essential course will provide you with a comprehensive foundation in US regulatory affairs to make your submission a success. Over two days, 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.
Delegates will be able to cement this knowledge through interactive workshops.
Suitability - Who should attend?
- Regulatory Affairs professionals with previous experience in medical devices, but who may be unfamiliar with the US market
- Those moving into Regulatory Affairs from other areas within a medical device company (Clinical Trials, Marketing and others)
- Anyone wishing to update their knowledge on US regulatory affairs for medical devices
Training Course Content
- Understand the scope of FDA regulation
- Consider the possible approval routes
- Investigate how devices are reviewed by the FDA
- Examine labelling and UDI requirements
- Prepare for inspections
- Learn where to find the information you need
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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