Company:SinTea Biotech S.p.A
Product: “Traumafix system” and other orthopedic devices
Date: 8/2/04
Require that validation activities be conducted using production units or their equivalents; or ensure that design validation also includes software validation and risk analysis, where appropriate. (21 CFR 820.30(g))
Issuer: Center for Devices and Radiological Health (CDRH)
