Your company has accepted the concepts of Agile and you’ve started one or more projects which use the approach. You’re making good progress, but you want guidance on getting the most out of this new method. In particular, you’re looking for how to document your project, how to address risk management, how to coordinate hardware and software efforts, and how to work in human factors engineering (none of which classically seems to fit the Agile mindset).
Instructors Nancy Van Schooenderwoert and Brian Shoemaker have  presented multiple workshops and courses to medical device audiences since 2009. They combine depth of experience in the Agile and engineering fields: hardware and software development, Agile coaching, regulated software for medical products, software quality, regulatory concerns, documentation, risk management.

Course Details

Picking up the thread from the introductory course, this session explores topics essential to any regulated medical product company applying an Agile approach for development. You’ll come away with a deep understanding of ways to avoid the false dichotomies that pit expediency against larger business needs - you’ll see how actions at the team level can improve overall flow of the work, and keep technical complexity from crippling later progress. You will also learn practical ways to address special needs of medical device work (such as documentation, risk management, hardware, or human factors...) without sacrificing any of the benefits Agile brings. 

Course Format - Full Day

  • 8:30 - 9:00  Check-in,  coffee and light breakfast
  • 12:00 - 1:00 Lunch break - Selection of items available and included in course fee
  • 5:00 pm - Course complete!
Each topic is reinforced through interactive exercises that all attendees can participate in, and most can be brought back to your workplace and used with the rest of your team members.
 
Our focus is on the core principles and practical ways to use them rather than on any one Agile methodology or framework. Our approach is compatible with Scrum, XP, and other Agile methods, and is based on experience working with a variety of medical device teams.

  • Morning and afternoon breaks with refreshments
  • Wi Fi connectivity
  • Free parking

Topics Covered

  • Lean Flow in a Medical Device Example
  • Handling Complexity
  • Applying Agile Beyond Software
  • Documentation in Agile
  • Risk Management within Agile
  • Where does Human Factors Engineering fit?
  • Agile Leadership and the Organization

Who Should Attend

  • Regulatory specialists
  • Functional managers - Software, Test, Hardware
  • Product / Project managers
  • Technical leaders
  • Business Analysts, Requirements Analysts
This is an intermediate course, and makes an assumption that attendees have either attended our introductory course, or have been involved in their company’s Agile adoption program for at least 6 months.