Case Study: FDA achieves compliance certification for medical devices with CAST

FDA Compliance for Medical Device Manufacturer

FDA, a major American medical equipment maker, needed to meet stringent FDA CFR 21 Part 11 and related HIPAA requirements across several product lines. To address this compliance challenge, FDA worked with CAST and its CAST AIP software intelligence platform to identify the top CWEs that needed remediation.

CAST compared the required rules with those already configured in CAST AIP and found eight additional rules were needed for full compliance. CAST added those rules within two months, helping FDA support compliance certification for FDA and HIPAA regulations, with the new rules permanently incorporated into CAST AIP.

FDA