About This Course

This 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.  The course consists of four main modules as listed below:


  1. Brief Regulatory Background
  2. Agile principles overview
  3. Backlog management
    • Design input, requirements, open anomalies, user needs vs system needs
    • Agile risk management
  4. 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

Instructors

Mike Russell Consultant, SoftwareCPR

Mike Russell is a Partner with SoftwareCPR®. He provides firm services such as development process assessments and improvement, Quality Management System reviews, and assistance with regulatory filings. He is also an expert in business agility and “agile and compliant” process transformation. Mike served on the TIR working group that created the AAMI TIR45- 2012 Technical Information Report Guidance on the use of Agile practices in the development of medical device software.


Register

  • Provides one person to connect to the course. Registration can be transferred to another person any time before 12/2/24. Refundable (minus credit card fees) until 11/30/24.





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