The course will help students understand FDA, EU and global perspectives on software validation by covering:
- General principles of software validation
- FDA design controls as applied to medical device software
- IEC 62304
- Mobile medical applications
- Off-the-shelf software use in medical devices
Students work on a project designed to determine software level of concern, define a software validation strategy, write a software validation plan, create software validation test procedures and test cases, and write a software validation report. They learn effective documentation and the regulatory requirements and expectations for software used in the medical device industry.