Process Validation
PCB Assembly Test Method Validation
Validation of AOI and functional testing methods for a complex medical-device printed circuit board.
AOIFunctional TestLabVIEWMinitab
SeededDefect ChallengeIPC 3ClassAOI + FCTMode
Engineering Domain
Process Validation
Validation work structured around objective evidence, traceable acceptance criteria, risk-based sampling, and documented execution. The focus is on producing defensible validation packages that can withstand internal quality review and external audit scrutiny.
IQ/OQ/PQTMVMinitabGage R&R95/90
Relevant case evidence
Process Validation
Cable Assembly Length Measurement TMV
Variable test method validation for overall-length measurement of flexible cable assemblies.
Custom FixtureTape MeasureANOVAMinitab
VariableMethod3Operators3Trials
Process Validation
Medalist i3070 ICT Platform IOQ Validation
Validation of a Medalist i3070 ICT platform for medical-device manufacturing acceptance testing.
Medalist i3070IOQCalibration RecordsEHR
PlatformScopeIOQPackagecGMPRelease