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Rocky Mountain Regulatory Affairs Society | Device Premarket Series

Wednesday, Jun 12, 2024
College Hill Library, Front Range Community College – 3705 W 112th Ave, Westminster, CO 80031

RMRAS’ Device Premarket Series will feature three, half-day courses with essential knowledge to help you develop and document your premarket device.  The three courses will focus on:

  • Design Control
  • Risk Management
  • Verification and Validation

Design Control (March 27) will teach you the basics of the design control process; how to create a design plan, inputs, and outputs; how to conduct a design review and effectively execute design transfer.

Risk Management (May 8) will explain the risk management process and types and purposes of risk analysis tools.  Time will be allotted to a real-life risk analysis example.

Verification and Validation (June 12) will walk you through the basic types of verification and validation studies, writing the verification/validation plan, documenting the results, and recovering from verification and validation failures.