Risk Management Documents

Downloads Available:

Risk Determination
Determining Risk Category and IDE Exemptions
510(k) Current Status & Considerations
Conducting a Well-Controlled Clinical Study When Clinical Data is Required
Drugs vs. Devices
Understanding the Similarities & Appreciating the Differences
The Top 5 Trial Complications
Is Your Trial Complex?

If an investigational device is Significant Risk (SR) or Non-Significant Risk (NSR)
If a NSR device study is exempt from certain IDE regulations
The current status of the 510(k) process with regard to clinical data requirements
To define considerations that should be given to conducting a well-controlled clinical study
To safeguard research participants while bringing safe and
effective products to the market as quickly as possible
The top five key areas that can complicate medical device trials