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. Students engage in interactive classroom discussions and an in-depth survey of the regulations, guidance documents and standards specific to medical device software and validation.

You will work on a project designed to help you 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. Overall, you will learn how to create these types of documents and activities while also learning the regulatory requirements and expectations for software used in the medical device industry.

Learning Outcomes

At the conclusion of the course, you should be able to

• Identify the different types of software regulated by the FDA and interpret the latest FDA regulations, guidelines and International standards applicable to medical device software
• Discuss software level of concern and use it to focus validation activities and develop an appropriate validation strategy
• Explain the different requirements for validation of device, manufacturing & quality system software and discuss how to differentiate between verification and validation in software testing
• Create a software validation plan, test procedure and software validation report that documents software validation activities and complies with regulatory requirements

Topics Include

• FDA Regulated Software, Regulations, Guidance Documents and International Standards
• Detailed look at IEC 62304
• Software Validation Planning and Strategy
• Digital Health

Working knowledge of:

• Google Workspace or Microsoft Office to submit assignments
• Canvas navigation links, modules, and using the inbox to communicate with the instructor

Additional Information

Please review section notes to view the full schedule.

Most required tools and materials are available on the FDA website for free.