With the increasing number of medical devices running on software, there is an enormous demand for quality assurance and regulatory affairs professionals who can address the validation, documentation, compliance and submission requirements unique to software-controlled devices. This how-to course covers the requirements for validation for all types of software, including Class II and III embedded medical device software, digital health apps, software as a medical device, medical device data systems, manufacturing software, automated test software, process software, quality system software, and spreadsheets. Student engage in interactive classroom discussions and an in-depth survey of the regulations, guidance documents and standards specific to medical device software and validation.
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.