If you’re using software to automate a process that is required by FDA, there is a good chance you’ll be required by FDA to validate that software to demonstrate that it accurately, reliably, and consistently meets the requirements for its intended use. ISO 13485 has similar requirements.
Nonproduct software is used across the full life cycle of a medical device and includes software used in the manufacturing process (e.g., software embedded in machine tools and statistical process control software); in design and development processes (e.g., CAD, CAM); software used to automate any part of the quality process (e.g., complaint-handling software); and software related to electronic records and signatures for documents required by regulation.
In this course, using hands-on exercises and case studies, you will learn how and when to effectively implement a nonproduct software validation program for medical devices that meets FDA and ISO requirements. We will also cover the role of risk management in nonproduct validation.