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Download Risk Management Documents

Risk Management Documents

Risk Determination

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?

You'll learn:

  • 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