R&D Workshop: Agile Software Development for Medical Device Systems

Tuesday, October 25 2016
7:30am - Registration and Breakfast
8:00-9:30am - Program

Located at:
NITA Training Center
1685 38th Street Suite 200
Boulder, CO 80301


Agile Software Development methods are being used for the development of medical device software, enabled by the guidance provided in an FDA recognized consensus standard, “AAMI TIR45:2012 - Guidance on the Use of AGILE Practices in the Development of Medical Device Software”. Since medical devices are often systems that include more than software, and as Agile methods are growing in use beyond purely software applications, guidance is needed on the application of Agile to the development of medical device systems. In this presentation, we will explore principles of Systems Engineering from INCOSE and ISO 15288 System Life Cycle Processes, and the principles of Agile scaling methods such as those defined in the Scaled Agile Framework (SAFe®), to find ways to gain value from Agile methods when creating systems that include more than software. 

Course Fee: $45 (non refundable but transferable within company)

About the Trainer:

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).

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