Medical Software Development Essentials

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:

1. Software Planning / Classification
2. Software Requirements / Traceability
3. Risk Management
4. Design Reviews
5. Software Testing (unit level, integration, design verification)