Technical Training

Agile Methods for Medical Device & Health IT Software

Objectives

This comprehensive 2 day programme explores agile methods as it pertains to IEC 62304 and other emerging standards for medical device and HealthIT software. The objective is to understand how agile methods and approaches can be effectively used for medical device and HealthIT software while ensuring IEC 62304 conformance and meeting regulatory expectations for software documentation.

Content includes

The course uses many of the concepts of AAMI TIR45 combined with the flexibility inherit in IEC 62304 and US FDA approach (including 21st Century Cures Act changes) to cover the topics listed below:

• Brief Regulatory Background – US FDA, EU
• Agile principles overview
  • Backlog management
  • Design input, requirements, open anomalies, user needs vs system needs
  • Agile risk management
• Incremental and iterative software development lifecycle management
  • Software risk management
  • Design output, design verification, design review
  • Usability engineering
  • Cybersecurity engineering
• Frequent release management
  • Design validation
  • Documentation
  • Maintenance

Who should attend

Quality Assurance and Regulatory Affairs professionals. Product Owners, Scrum Masters/Coaches, software development managers/engineers, risk management, and test engineers.

Upcoming dates:

No training dates available at the moment.