COURSE DATES: May 9 – 12, 2022 (16 hours of training)
HOURS: 11 am until 3 pm EDT each day
TRAINING LOCATION: Virtual – live online
COST: 4 half days for $1,920 per person
Only a limited number of discounted seats are available. For more information on the course, use the form below.
- Our course is framed around IEC 62304 and how the standard can be used to ensure agile methods and approaches to software development.
- Discuss the proper activities and deliverables for safe and effective software.
- Uses concepts from AAMI TIR45 as well to help communicate how agile methods can, when used properly, improve software quality.
- Reference US regulations and FDA guidance to address potential gaps that can occur with some agile approaches.
- Understand how backlog management, development iterations, and release cycles can easily align with the intent and expectations of regulators and auditors.
- Discussion on tools and the very important role they MUST play in the effective use of agile methods for medical device and digital health software.
- Integrated exercises designed to apply learning!
This 16 hour course will be taught by Mike Russell and Ron Baerg of SoftwareCPR®.
Mike was a member of the AAMI working group that developed TIR45 Effective Application of Agile Practices in the Development of Medical Device Software. Ron is a current member of the AAMI working group working on the 2nd edition of TIR 45. Full credentials on our website: www.softwarecpr.com
Who Should Attend?
- Quality Assurance and Regulatory Affairs professionals
- Product Owners
- Scrum Masters/Coaches
- Software development managers and engineers
- Risk management owners
- Test engineers
This course will provide a clear understanding of requirements versus areas of flexibility and provide ideas and suggestions to use for gap analysis, auditing, and software vendor and OEM qualification and management as well as improving articulation and defense of your approaches to regulatory bodies, internal quality assurance, and regulatory affairs departments.
Virtual course delivered by Zoom.