Rocky Mountain Regulatory Affairs Society
Rocky Mountain Regulatory Affairs Society



 Rocky Mountain Regulatory Affairs Society 

Second course in the Device Premarket Series

Wednesday: May 8, 2024
9:30 am - 1:00 pm
College Hill Library, Room 211
Front Range Community College, Westminster, Colorado


RMRAS’ Device Premarket Series features three, half-day courses with essential knowledge to help you develop and document your premarket device.
The first, Design Control, held March 27, taught 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.
Some comments from the attendees:

"Overall excellent content! I learned a lot."
"Presenters did a good job of summarizing the material and engaging the audience."
"Very good explanation of Design Control."

The next two in the series are:

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.

The courses have a variety of fee options for your use depending on how many people are attending.  See below:

Single Course Registration
The single registration fee for one of the Premarket Series courses is $325.00 including morning refreshments and course materials.

Group Discount Registration for Single Course
First two people from one company for one course is $325/each.
Third person from same company for same course is $295.
Fourth person from same company for same course is FREE!
[The free registration must be used for the same course as the others registered.]

The Payment Page on the website has all the details as to how to take advantage of these different options.

To register, go to

For questions or additional information, contact Nan Matthews,


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Rocky Mountain Regulatory Affairs Society


Phone: +1 (303) .843-6414


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