January 23 - All Day
Developing software in compliance with the FDA Design Control regulations and international standards is challenging.
This one-day course provides background and suggestions for developing software in a manner that meets applicable FDA guidance documents and international standards, such as IEC 62304.
Topics include:
- Software Planning / Classification
- Software Requirements / Traceability
- Risk Management
- Design Reviews
- Software Testing (unit level, integration, design verification)