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
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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.”
Format
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.
Materials
Attendees will receive an electronic copy of the
course materials.
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