I work for a medical device component supplier who is now being asked to register as a contract manufacturer for a specific device. As we have been supplying components for many years, we comply with most of 21 CFR 820. The primary exception is design. In this case, we still will not be design responsible, but we do design tooling for the components and tooling used for assembly of the device.
I am concerned about the QSIT requirements regarding design controls as our tooling function has traditionally been excluded from most requirements because ISO auditors focus on the end product. What level of design controls are typically expected by FDA inspectors related to tooling and assembly equipment?
I am concerned about the QSIT requirements regarding design controls as our tooling function has traditionally been excluded from most requirements because ISO auditors focus on the end product. What level of design controls are typically expected by FDA inspectors related to tooling and assembly equipment?