VALIDATION OF CLASS I DEVICE SOFTWARE KEY TO DESIGN CONTROL COMPLIANCE, FDA'S TRAUTMAN SAYS; VALIDATION MUST BE DONE EARLY IN DEVELOPMENT PROCESS
This article was originally published in The Gray Sheet
Executive Summary
FDA inspection of Class I device software for compliance with design controls will focus on validation requirements, Kim Trautman, quality systems expert in the agency's Center for Devices and Radiological Health, said Oct. 30 at a Regulatory Affairs Professionals Society meeting in Bethesda, Maryland.