FDA guidance for medical device software can be found in, “General Principles of Software Validation; Final Guidance for Industry and FDA Staff” All software, from machine-tool embedded software, to materials-planning software, to simple spreadsheets, to the software controlling a medical device is subject to these regulations. In cases where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software), the device manufacturer is responsible for compliance with FDA regulations, not the software developer. This guidance (linked below} outlines general validation principles that the FDA considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085371.pdf
Research by Diane Meade
