Agile for Medical

Device Development

Thursday, October 19, 2017 at 10 am PT

As medical device companies adopt Agile development, some still have lingering questions about applying the methodology’s lean principles to safety-critical applications.

This webinar provides an overview of AAMI TIR45 — the Association for the Advancement of Medical Instrumentation’s guidelines for Agile — detailing how and why it should be used for safety-critical, regulated software development.

On Thursday, Oct. 19, join Jama Software and Kelly Weyrauch, AAMI University instructor and TIR45 expert, as we answer questions and discuss:

  1. Interpreting Agile principles from a Systems Engineer’s perspective
  2. Guidance on TIR45 best practices
  3. Safety risk management and hazard analysis

Kelly Weyrauch

Founder, Agile Quality Systems

Cary Bryczek

Senior Solutions Architect, Jama Software

Kelly 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.