Published on December 5, 2016

Agile in QMS: Bernhard Kappe Presentation Fall 2016

The presentation covers lessons learned in applying agile methods to medical device software development:

  • A Short Introduction to Agile
  • Why Agile Makes Sense for Medical Device Software Development
  • How to be Agile within a Quality Management System
    • Risk Management
    • Human Factors
    • Verification Driven Development
    • Testing Automation and Requirements Management Tooling
  • Top 5 Mistakes in Agile Implementation

At Orthogonal, we design, build and launch software and applications for medical devices. Our extensive experience with FDA and HIPAA regulations reduces time to approval.