Medical Device Production and QMS Software Validation Training
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. In this course, you will learn how and when to effectively implement a non-product software validation program for medical devices that meets FDA and ISO requirements. We will also cover the role of risk management in non-product validation.