Regulatory

The Regulatory Affairs Fellowship is a facilitated learning experience for students learning the reality of the regulated industry of Medical Devices. They are able to take the theoretical lessons of the class room and literally implement it in practical implications, with real world situations and consequences.

The Regulatory Affairs fellows come through the program gaining the following marketable experience:

  • The ability to do a full regulatory assessment, to determine the appropriate regulatory pathways and to build a submission strategy for a medical device product.
  • Help write a 510(k) submission that will be submitted to the FDA.
  • Help write and edit quality system documents, including SOP’s and Design Control documents
  • Participate, when available, in company audits and FDA phone calls during the review process, including possible involvement in pre-submission meetings with the FDA.
  • Interact with actual companies, and provide valuable feedback on work they have done for the company during consulting visits.

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