This programme is funded by Connected Health Skillnet
Connected Health Skillnet is co-funded by Skillnet Ireland and network companies. Skillnet Ireland is funded from the National Training Fund through the Department of Further and Higher Education, Research, Innovation and Science
Agile Methods for Medical Device & Health IT Software
Objectives
This comprehensive 1 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
03 June 2021 (9:30 - 17:30)
Virtual Classroom, Online