Technical Training

Being Agile and Compliant (Medical Device & Health IT Software)

Objectives

This comprehensive course provides an overview of IEC 62304 compliance when viewed from an agile perspective. It incorporates the concepts from AAMI TIR 45 with the primary objective being to understand how agile methods and approaches can be effectively used for medical device and HealthIT software while ensuring IEC 62304 conformance and meeting US FDA expectations for software documentation.

Instructor-led, virtual delivery over 3 x half days (11am - 4pm each day)

Content includes

The course will 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

Each module consists of instruction, Q&A, and discussion of examples. Course uses SCRUM concepts for illustration, but focus is on any iterative and incremental approach. Standards that are briefly mentioned include ISO 14971, IEC 62304, IEC 82304, IEC 62366, cybersecurity (AAMI TIR 57, emerging IEC 81001-5-1), but also will communicate US FDA expectations as appropriate.

Who should attend

System Engineering professionals, Quality Assurance and Regulatory Affairs professionals, Product Owners, Scrum Masters/Coaches, Software Development Managers/Engineers, Safety/Risk Management, and Test Management/Engineering.

Upcoming dates:

No training dates available at the moment.