This introductory course, intended for managers, quality, regulatory, and other roles in addition to software development, presents the information you need in order to plan your transition to an Agile approach.  Whether you are brand new to Agile, or have tried Agile and found your approach isn’t giving the hoped-for results, this course will fill in what you need to know.
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

The Agile approach is well established in other industries, and adoption of Agile in medical device development has been increasing in the past five years. Experience is showing that Agile teams achieve higher quality and safety than before, while still meeting regulatory requirements. By walking through a safety critical project, Nancy Van Schooenderwoert and Brian Shoemaker delve into several key areas for applying Agile methods in the medical device context.

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!
Rather than focus on any methodology (e.g. Scrum, Kanban, Crystal, XP), this course aims to build understanding of the fundamentals which underlie all Agile methods, so that teams can determine their own blend based on what works in their context, and address the issues which inevitably come up in Agile adoption. Practical illustrations will be demonstrated by use of specific tools, but the tools themselves are not the focus.  Interactive exercises reinforce what you learn, as you get to know colleagues in other companies. You won’t be struggling to stay awake!

  • Morning and afternoon breaks with refreshments
  • Wi Fi connectivity
  • Free parking
  • Book included in your Course fee: "Agile Methods for safety-Critical Systems"

Topics Covered

  • Countering myths and preconceived ideas about Agile methods
  • Understanding the REAL regulatory requirements
  • Agile is a mindset, not a canned method
  • How to choose an Agile pilot project
  • Agile in hardware and software development
  • Applying Impact Mapping and Story Mapping practices to chart the way
  • How to move from traditional specs to Agile stories
  • Bringing everyone on board, not just software
  • Applying Agile in larger organizations / projects
  • Metrics - how to use them; what to avoid!

Who Should Attend

  • Regulatory specialists
  • Functional managers - Software, Test, Hardware
  • Product / Project managers
  • Technical leaders
  • Business Analysts, Requirements Analysts
This will be an introductory course, and makes no assumptions about previous knowledge or experience with the Agile approach.