University of Minnesota
Software Engineering Center

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Kelly Weyrauch - Agile and Medical Device Software

Date of Event: 
Thursday, January 5, 2012 - 5:30pm
University of Minnesota, Keller Hall, Room 3-115

Agile and Medical Device Software topics include recommendations from a paper on Agile for Medical Device Software by the AAMI committee including:

  • Align Agile Values with regulated Values
  • Add Agile to an existing, robust, effective Quality Management System
  • Align Agile's Incremental/Evolutionary lifecycle with (mis)expecatations of more Linear models

In addition the following will be discussed::

  • What does the FDA think of Agile?
  • Challenges unique to Medical Device Software
    • = Continuous Release
    • = Myths, misperception, miscommunication, and mistakes

Audience questions, discussion and participation will be encouraged!


Directions can be found on the map of the Electrical Engineering/Computer Science Building.
Check out the detailed map by clicking the “close up” button.


Keller (EE/CS) 3-111 (Look for signs)

This Month's Meeting
Program Manager: 
Megan Graham (Medtronic)
Kelly Weyrauch (Medtronic)
Agile and Medical Device Software
FileTwinSpin on Agile Jan2012.pptx270.31 KB

5:30 - 8:00 p.m. at The University of Minnesota
5:30 start for networking, 6:15 start of meeting


We have reserved parking at the Washington Avenue Ramp! If there is event parking, tell the parking attendant when you enter that you have a reservation with TwinSPIN. If there is no event parking, take a ticket and tell the parking attendant when you leave that you have a reservation with TwinSPIN.

Speaker Bio: 

Kelly Weyrauch is a Senior Principal Systems Engineer at Medtronic, with 20 years experience in delivering medical device software for pacing and defibrillation systems. As a leader of the Agile movement within Medtronic, he leads the adoption of Agile within the context of the highly regulated, Class III medical device software environment. As one of the lead authors on the AAMI Committee that produced the Technical Information Report, "Guidance on the Use of Agile Practices in the Development of Medical Device Software", Kelly worked with other industry and FDA leaders to provide guidance to the medical device industry and regulatory worlds. As a leader in the Agile community, he has blazed the trail for using Agile in the regulated world, overcoming barriers by tailoring the use of Agile to align with regulatory expectations. Kelly is an experienced definer, designer, teacher, facilitator, and coach. He has a BS in Mechanical Engineering from the University of Minnesota, and a MS in Software Design and Development from the University of St. Thomas.