FDA releases Final Guidance on Content of Premarket Submissions for Device Software Functions.  This final guidance provides requirements for the recommended documentation manufacturers should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s Guidance for the Guidance for the Content of Premarket...Read More

Tampa, FL, May 10, 2023.  Crisis Prevention and Recovery, LLC, dba SoftwareCPR® announced today that Windi has joined SoftwareCPR® as a Partner. In her role, Windi will lead the expert regulatory and quality team, bringing a unique client-side perspective for both US, Canada, UK/EU, and Japan markets. Windi’s career path is one marked by a...Read More