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


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



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

Start Date June 03, 2021
Time 09.30 - 17.00
Delegate Price Member
€890 (+VAT),
€1,375 (+VAT)