IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software

Course Dates: TBD

COST: 3 Full Days for $2,400.00 (Fully transferable at any time.)

This course focuses on ensuring the participants are aware of the relevant standards and US regulations that drive the processes for creating medical device and HealthIT software, and the activities and documentation expected by NB auditors and regulators. The course is framed around IEC 62304:2015 but also addresses topics outside the scope of 62304 but important to software validation.

Beyond the standards and regulations, our approach is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Our training is helpful for regulatory, quality, and software dev roles, both management and contributors. We discuss the details of the software lifecycle process necessary for compliance.

Our course is frequently updated! The current standard format course covers the topics listed below:

• New module focused on AI/ML training software & risk management
• Proposed IEC 62304 2nd Edition update!
• All compliance discussed using iterative/incremental development models
• New FDA premarket submission guidance details and impact (and alignment with IEC 62304 2nd Edition)
• Cybersecurity activities aligned with 62304 using IEC 81001-5-1
• ISO 14971 risk management for SaMD and detailed software hazards analysis
• Brief Regulatory Background – US FDA, EU
• Types of Software – Medical Device, HealthIT, Decision support, AI/ML, Cloud Services, Mobile Medical Apps, Personal Health / Wellness
• SaMD product level activities – design controls
• Overview of related standards and guidance 82304 Health Software, 80002-1 Risk Management Background and Structure, 62366 Usability
• Using 62304 software safety classes to prioritize rigor and documentation
• SOUP, Off-The-Shelf Software, SBOMs
• Requirements – Understanding Design Input and the sometimes confusing “left side” of the ‘V’
• Architecture and Detailed Software Design – Differentiating unregulated, Class I, and Class II/III software
• Implementation, coding, unit verification/code review
• Software verification, automated testing, test planning
• Post-Market activities for SaMD and SiMD
• Release, Configuration Management, and Problem Resolution / Rapid release cycles
• Practical, real-world examples and discussion
• Workshops and exercises integrated throughout teaching modules

This 3 day course will be taught by Brian Pate of SoftwareCPR.

Morning coffee/refreshments, hot lunch, and afternoon snacks/refreshments provided!

Full credentials on our website:  https://www.softwarecpr.com/consultation/

Who Should Attend this 62304 Public Training Course?

Quality Assurance and Regulatory Affairs professionals

This course will provide a clear understanding of requirements versus areas of flexibility and provide checklists and questions to use for gap analysis, auditing, and vendor and OEM qualification and management.

Product Owners, Scrum Masters/Coaches, software development managers/engineers, risk management, and test engineers

This course provides examples, checklists, and partial templates as well as improving articulation and defense of your approaches to regulatory bodies, internal quality assurance, and regulatory affairs departments.

Just want info? Email training@softwarecpr.com