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About Agile Quality Systems

I'm Kelly Weyrauch. I formed Agile Quality Systems in 2013 to help medical device organizations improve the performance and effectiveness of their quality management system. My experience in software development, systems engineering,  quality system development, auditing, coaching, and instructing gives Agile Quality Systems the expertise to assess opportunities and provide practical solutions.

Would you like to hear others' impressions of my capability, experience, and style? Contact me for references.


My Experience


  • Provider of custom courses on Agile Development techniques, based on Scrum, Extreme Programming, and Kanban - delivered over 50 courses for more than 1000 participants.
  • SAFe® Program Consultant (SPC) - delivered more than 80 courses on the Scaled Agile Framework (SAFe®) for more than 1600 participants.
  • Lead Instructor for the Association for the Advancement of Medical Instrumentation (AAMI) course on AAMI TIR45:2012 “Guidance on the use of AGILE practices in the development of medical device software”.
  • Provider of Quality Management Systems and process training on topics related to the FDA Quality System Regulation 21CFR820, ISO 13485, IEC 62304, ISO 14971, and others.
  • Adjunct Instructor for St. Cloud State University's Master of Science in Medical Technology Quality program.


  • 30+ years medical device software & system development
  • 20+ years Agile practitioner, trainer, Agile Transformation Coach,
    Certified Scrum Master, Certified SAFe
    ® Program Consultant
  • Leader of the movement that brought Agile Software Development to Medtronic's Cardiac Rhythm Disease Management organization.
  • Lead author of AAMI TIR45 “Guidance on the use of AGILE practices in the development of medical device software
  • Creator, owner, and defender of QMS processes for software development, systems engineering, internal audit, and others.
  • Auditor and auditee, who knows how to give and receive constructive criticism focused on improving the performance of teams and organizations.

Decades of medical device experience is too much to summarize.

For more information, contact me here
and connect with me on LinkedIn