IMARC | Medical Device CRO

Medical Device CRO

Significant Risk / Non-Significant Risk Determination

Download our Risk Determination Whitepaper

Determining the risk category and regulatory exemptions of investigational device studies

The purpose of this whitepaper is to clear up confusion about the process for determining if an investigational device is Significant Risk (SR) or Non-Significant Risk (NSR) and if a NSR device study is exempt from certain IDE regulations.