Agile Methods for Medical Device Software - with SoftwareCPR
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 regualtory 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 – 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.
Brian Pate is partner and General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®). Brian began his career in clinical research over 36 years ago with the Department of Anesthesiology at the University of Alabama developing closed-loop control systems for the automated delivery of gases and control of ventilation. He then moved into the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time, safety-critical, embedded and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical.
He has provided training internally for FDA, has taught for many years alongside FDA’s internal experts, and was a member of the working groups that created AAMI TIR32 (software risk management) and AAMI TIR45 (use of agile methods for medical device software). Brian is also member of the Underwriters’ Laboratories (UL) Standards Technical Panel 5500, Remote Software Updates.
Mike Russell is an expert in business agility and is key to SoftwareCPR® “agile and compliant” process transformation and improvements. 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. He combines experience serving as both a C-level executive, including as Chief Operations Officer for a top 60 U.S. bank, and as a trusted advisor to CEOs and other top executives at diverse organizations in multiple industries. This has provided him with first-hand experience dealing with many opportunities and challenges facing executives today, especially with rapid change and digital transformation.
*This training is 50% funded by Connected Health Skillnet please contact firstname.lastname@example.org for further details
Delegate cancellation policy
Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.
Photography at events
There may be a photographer and videographer at the event and we may publish images from this event on our website(s) and on our social media accounts.