Medical Device and Licensing Requirements for US Expansion


Project scope
Categories
International development Public healthSkills
medical devices researchThe goal of this project is to research medical devices and licensing requirements for our US expansion, create a comprehensive list of documents needed, and if possible, complete the application to apply for a drug establishment license and a wholesaler and distributor to sell products nation wide with registration in as few states as possible.
By the end of the project, students should demonstrate:
- Understanding of the medical device and licensing requirements for US expansion.
- Creation of a comprehensive list of documents needed to apply for a drug establishment license and a wholesaler and distributor license.
- If possible, completion of the application to apply for the licenses.
Final deliverables should include:
- A comprehensive list of documents needed to apply for the licenses.
- If possible, the completed application to apply for the licenses.
- A written report explaining the research and findings.
Weekly meetings with the students and the management team
access to existing research and data on regulatory affairs
access to company information
About the company
Medical device and pharmaceutical company since 2017, our business is primarily B2B