Research, analysis, and development of global medical device regulatory affairs strategic plan

Circle Neurovascular Imaging (CNVI) aims to improve the standard of care for stroke patients by providing physicians critical information assisted by artificial intelligence (AI) through their innovative software platform, StrokeSENS, which is designed to aid the clinician in making quicker, more accurate decisions about patient management. StrokeSENS, has partial clinical approval in the EU and USA (FDA), and is currently under review by Health Canada. In this key go-to-market and globalization phase, CNVI will benefit from the proposed internship activities in support of strengthening CNVI’s regulatory approval process and optimizing the globalization strategy. The intern, working closely with the companies medical and regulatory affairs departments, will aid and support the company in the research, planning, execution, and documentation of key regulatory requirements including optimizing internal quality systems reporting, preparation of regulatory applications, and strategic analysis of new jurisdictional requirements.

Faculty Supervisor:

Roman Krawetz

Student:

Partner:

Circle Neurovascular Imaging

Discipline:

Life Sciences

Sector:

Manufacturing; Professional, scientific and technical services

University:

University of Calgary

Program: