MAUDE
notableCitations
NA. ARC-One Solutions received information regarding Regulated Software Application (RSA), Version 2.0 (BK200512). Specifically, an issue related to importing blood products into RSA 2.0 from a blood center's own facility, and the ability to ship these products to customers for
Penetration testing, SBOM, threat modeling, and 524B submission support for MedTech.