Katie brings more than 10 years of experience introducing medical devices to market through the commercialization team at Sanford Health. A regulatory master, her many areas of expertise include:
- Bringing a novel drug-device combination product from idea to first in man
- Developing and managing a quality system with design control
- Design transfer and change management
- Managing vendor/supplier qualifications, audits and aseptic packaging
- Developing device evaluation strategies
- Filing and effectuating investigational new drugs (IND) or investigational device exemptions (IDE)
