Fast Can be Safe: Coaching Agile Medical Software Development

Nancy Van Schooenderwoert and Brian Shoemaker

Practitioner Workshop


This workshop focuses on the intersection of Agile practices and the realities of safety-critical, regulated product development.

Are FDA/ IEC software quality and validation requirements stopping your teams from being Agile? It doesn’t have to be that way.

There is no contradiction between being fully Agile and fully compliant with all the medical regulatory requirements in the USA or in Europe. This workshop will cover varying levels of safety-critical development for those with an intermediate or expert level of Agile practices knowledge. Our focus is on medical product development but the concepts behind those regulations apply to other safety-critical industries as well.

Who Should Attend

  • Agile Coaches
  • Managers
  • Team leaders and technical leads
  • Software Developers
  • Requirements analysts and business analysts
  • Validation and Quality Assurance personnel

What you will learn

  • Perceived problems of Agile in a regulatory environment
  • How coaching Agile medical work differs from Agile in other industries
  • Overview of regulations (European and/or US, depending on attendees’ interests)
  • How Agile development improves speed and quality without losing regulatory compliance
  • How to stay Agile and still use standards, SOPs, and risk management effectively

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Nancy Van Schooenderwoert was among the first to apply Agile methods to embedded systems development, as an engineer, manager, and consultant. Beginning in 1998 she has led Agile change initiatives beyond software development in safety-critical industries such as medical devices, flight simulation, factory automation, and has coached clients in the art of Agile technical and management leadership. A contributor to Agile Times and Cutter IT Journal, she also served on IEEE 1648 Agile Customers committee, and as a track co-chair for Agile 2013. She speaks at numerous conferences worldwide, and is past president of Greater Boston’s premier Agile user group, Agile New England. Nancy is founder and Principal Consultant at Lean-Agile Partners, Inc.


Brian Shoemaker consults for healthcare products companies in computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S. Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.