Dimensions, CTF/CTQs and proposed datam structures are determined after early customer communication and a formal print review. Once an IQ report is drafted and the PFMEA, control plan and process flow are in place, our customers receive a formal process characterization report that highlights all of the scientific methods used to determine the nominal process, as well as the parameters used to challenge the process (DOE).
No validation: Prototype tools
ISO 9001 Standard: Non-medical customers, included in quote cost
ISO 9001 Custom: Non-medical customers, included once scope is understood
ISO 13485 Standard: All medical customers, included in quote cost
ISO 13485 Custom: All medical customers, included once scope is understood