Has anyone undergone a BARDA (HHS) audit as part of their grant process? I'm vaguely told that it is similar to a ISO 13485 certification process, but I've not been able to find any agenda's or reports on line. Rumor has it that the BARDA audits are much more rigorous. Thanks.
Office of Inspector General of the U.S. Department of Health & Human Services (HHS) - The Food and Drug Administration's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices
Full Report - https://oig.hhs.gov/oas/reports/region18/181630530.pdf