Our General Manager and Partner, Brian Pate, along with our expert affiliate, Mike Russell, will be teaching a one-day training course through Irish Medtech/Ibec (https://www.irishmedtechassoc.ie) for Ireland-based medical device and HealthIT companies on Thursday, November 19, 2020. The course will be delivered virtually/online. This course condenses the agile topics covered in our 3-day IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course into a single day. The course 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 US FDA expectations for software documentation.
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
- 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
As with all SoftwareCPR® courses, our goal is to not only help our students understand the regulations and applicable standards, but to also understand the intent of the writers – allowing us to embrace the principles and concepts of quality and efficacy underlying them.
Download this brochure to learn more: Agile methods for medical device software training – Irish Medtech – Nov 19
