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