Kelly Weyrauch has more than 30 years of software and systems development experience, and 20 years of focus on software processes and quality systems for medical devices. As an independent consultant, he works with software and systems creators to apply Agile concepts and Quality Management System requirements to the unique context of their development environment. As a leader of the Agile movement at Medtronic, he has worked with project teams to evolve Agile Principles and Practices in the context of a robust Quality System. As one of the principal authors of AAMI TIR45 Guidance on the use of AGILE practices in the development of medical device software, Kelly has worked with the FDA and industry leaders on the application of Agile practices to the medical device world. As an experienced software and systems developer, and an ASQ Certified Quality Auditor, Kelly helps teams to align the requirements of medical device regulations and standards with the practical realities and constraints of complex system development. Kelly has a BS degree in Mechanical Engineering from the University of Minnesota, and a MS degree in Software Design and Development from the University of St. Thomas (Minnesota).