Clinical Study Types
- Non-significant risk (NSR) and significant-risk (SR) studies (IDE)
- Exploratory/Feasibility, Pilot, Pivotal, Post-market
- Controlled, randomized, blinded
- Single center, multi-center
- Healthy volunteers, inpatient, outpatient
- Procedure focused, product focused
- Engineering studies
- Benchmarking and baseline studies with acquired devices
- Market readiness studies for commercial launch
