01Sensing-site geometry
Release controlRelease site size, position, reference geometry, contact opening, orientation, body datum, and non-sensing zones.
If it is missingThe patch fits mechanically while the sensing geometry differs from the OEM evaluation.
02Printed routing and dielectric
Release controlDefine traces, widths, clearances, crossovers, dielectric, flex zones, resistance, continuity, isolation, and registration.
If it is missingRepeated flex or conversion exposes or damages conductors.
03Electronics and connector lands
Release controlName component pads, connector, tail, pin map, surface finish, reinforcement, attachment, and supplied or excluded parts.
If it is missingThe circuit image implies electronics that are not controlled in the BOM or test scope.
04Strain and flexibility
Release controlMap rigid islands, reinforced transitions, bend paths, adhesive-free hinges, cable exits, and package supports.
If it is missingStiffness concentrates at a trace or connector transition.
05Wearable material zones
Release controlRelease backing, adhesive or hydrogel, foam or nonwoven, liner, breathable or non-contact areas, labels, and edge margins.
If it is missingConverted materials shift site exposure or flexible behavior.
06Inspection and OEM handoff
Release controlDefine print, dimensions, electrical tests, component or connector checks, flex sample, labels, package, and excluded device tests.
If it is missingA patch-level check is mistaken for validation of electronics, algorithm, wear, or clinical outcome.