DHF
A US design controls term from the former Quality System Regulation (21 CFR 820.30). The QMSR, which incorporates ISO 13485, no longer defines it, although many companies keep the name for their design and development file.
A US design controls term from the former Quality System Regulation (21 CFR 820.30). The QMSR, which incorporates ISO 13485, no longer defines it, although many companies keep the name for their design and development file.