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Event Registration - The Application of Agile to the Development of Medical Device Systems - September 2019

Start Date:
Wednesday, September 25, 2019
End Date:
Friday, September 27, 2019
8:00 AM - 2:30 PM Eastern Daylight Time

For many years software development teams have been using Agile Software Development methods, but Agile is not just for software. Agile’s Lean Product Development principles also apply to the development of hardware-based products and systems. This two and a half day course goes beyond small-team and software-only applications and demonstrates how Agile practices can be used in the development of medical device systems.

Registration Fees:

  • AAMI Members: $2135
  • Nonmembers: $2435
  • Government Employees: $950


Program Outline


DAY 1 | 8 AM-5 PM
Agile Overview, Assessing Your Organization's Current State; Agile Manifesto Principles; The Systems Engineering Engine
System and Processes;
Product Development Lifecycle Models; Agile Adoption Models

DAY 2 | 8 AM-5 PM
Stakeholder Expectations, Requirements, Definitions, and Agile Stories; Verification; Agile Software Practices Applied to Hardware and Mechanical; Backlogs for Feasibility, Spikes, Enablers; Release/Increment Planning; Satisfying the Quality Management System; Safety Risk Management, Hazard Analysis

DAY 3 | 8 AM-2:30 PM
Pending Update



Program Objective

Building on the concepts of the Effective Application of Agile Practices in the Development of Medical Device Software, this course will explore ways to apply Agile methods in the context of developing a medical device system that includes more than software. We will discuss specific ways to integrate Agile Methods and Systems Engineering techniques.



Target Audience

Systems Engineers, Software/Mechanical/Electrical Developers and Testers, Program Managers, Architects, and leaders of organizations developing complex healthcare products, whether those are large Healthcare IT systems, electro-mechanical systems with or without embedded software, or complex systems with multiple hardware and software subsystems.

Because this is an advanced course on the application of Agile, attendees should have a basic knowledge of Agile principles and practices, such as might come from Agile/Scrum training, or having attended the AAMI course related to AAMI TIR45:2012,“Effective Application of Agile Practices in the Development of Medical Device Software.”


Using a combination of lecture and discussion and exercises, this course will be a workshop where attendees apply the lessons of the course to their own context. Exercises are expected to be highly interactive, where attendees discuss their real-world scenarios and learn from each other.


Attendees will receive an electronic copy of the course materials.

  • Event Location
    • Address:
      AAMI Center for Excellence (ACE)
      901 North Glebe Road Suite 300
      Arlington, VA 22203
  • Hotel Info

    • Course Location: AAMI Center for Excellence (ACE)
      901 North Glebe Road Suite 300
      Arlington, VA 22203
      Phone: (703) 525-4890

      For further information about the hotels near AAMI, transportation, and local attractions, please visit the AAMI website at Hotel Reservation Information

  • Event Notes
    • Substitutions, Transfers, and Cancellations. . . In the event you are unable to attend this course, you may transfer your registration to a qualified colleague or apply your registration fee to a subsequent program, on a space-available basis. All substitution, transfer, and cancellation requests must be made in writing to AAMI Customer Service.

      Send a colleague to attend in your place . . . Substitutions can be made at any time prior to a program without penalty. No substitutions will be honored once a program begins.

      Transfer to a subsequent program . . . AAMI allows a one time transfer to a subsequent program as an alternative to cancellation. Transfer requests must be received by AAMI in writing (via e-mail or fax) no later than one week prior to the start of the originally registered program. (Please note: for those requests received within one week of the program, AAMI will assess a $400 transfer penalty in addition to the registration fee). Transfer requests must state alternate name and date of the program choice. Since programs are not all priced identically, the registrant is responsible for any increases in registration fees resulting from the transfer. No refunds for the difference between program prices will be made should the price of the program choice be less than the price of the originally registered program. Any request for a transfer beyond this one-time allowance will be treated as a cancellation (See Cancellation Policy).

      Cancellation . . . If AAMI receives a cancellation request at least one week prior to the program date, the registration fee minus a $400 cancellation fee will be refunded. No refunds will be granted for cancellations received by AAMI less than one week before the program.

      No Shows . . . Failure to attend a program for which you are registered will result in forfeiture of registration fees.

      AAMI Membership . . . Are you entitled to the member discount? Please call (800) 332-2264, ext. 1214, before you register and find out. If you are not a member, join AAMI for a special rate of $250 for an Individual Membership and $310 for an International Individual Membership to receive a discount on your registration fees.

      Course Confirmation . . . Confirmation notices will be distributed one week after your registration has been processed. You must have this confirmation to ensure course attendance.

      Contact Information . . . Your contact information will be provided on an attendee roster that will be distributed to course attendees and faculty. If you do not want your telephone number, fax number, and e-mail address provided to course attendees and faculty please email AAMI Customer Service. (This does not apply to AAMI's on-line membership directory.)

      Note . . . Please confirm course availability prior to submitting payment and making travel reservations. AAMI is not responsible for any airline or hotel cancellation fees if course availability is not confirmed prior to making travel reservations.

Registration is closed.