What does one need to know about IEC 62304?
In our 3-day 62304 Training course, we flow through the software development lifecycle drawing attention to requirements of the standard as well as related standards and always current FDA expectations from our experience. The topics we plan to cover in our 2019 course are below.
Topics:
- Regulatory Background – US FDA, EU MDR
- Types of Software – Medical Device, Health-IT, General Wellness, Cloud Services, Mobile Medical Apps, Personal Health Software
- Design Controls / 62304 / 82304 in the context of a system
- Overview of related standards and guidance 60601-PEMS, 82304 Health Software, 80002-1 Risk Management Background and Structure, Cybersecurity 80001-1 IT Networks, 62366 Usability, Privacy HIPAA and EU
- Use of Standards
- 62304 Software Safety Classifications / Contrast with FDA LOC
- Software Development Process Planning / Agile Methods Planning
- SOUP (open source, commercial), Legacy Software
- “Real” Design Input / Requirements / Formative usability
- Architecture and Detailed Design
- Implementation, coding, unit verification
- Integration and integration testing
- Software Risk Management
- Probability and Severity related to software
- Harms, Hazards, Identifying Causes and Risk Controls
- Process as Risk Control
- Managing Risk after release
- Document Hierarchies and Traceability / Electronic records / Data Models
- Maintenance Process / Problem Issue and Defect Management
- Validation / 82304 / Summative usability
- Release, Configuration Management / Rapid release
- Networked Devices / Cybersecurity / 80001-x
- SaMD / Design Review
One reason for the popularity of our course is our background and experience with many, many examples of approaches no matter your SDLC, type of software, or organizational structure. Beyond the regulations and standards, our approach is to educate on the intent and current expectations so that the participants are able to make informed decisions in the future. Learn more at our 62304 Training page.
