Consolidating three suppliers into one validated source
A surgical-device OEM was juggling three local shops with inconsistent CMM data and 6-week lead times, risking a launch. We onboarded the full part family on one validated process and cut lead time 40%.
Background
A US surgical-device OEM had spread a family of 316L stainless components across three local machine shops. Inconsistent inspection data and 6-week lead times were creating quality risk and threatening a product launch date.
The challenge
Three suppliers meant three sets of inspection methods, three lead times and no single accountable source. The OEM needed consistent, documented quality across the whole part family and a process they could validate once and trust under ISO 13485.
Our approach
- 1
Onboarded the complete part family onto our 5-axis CNC cells so every part came from one controlled process.
- 2
Established documented First Article Inspection (FAIR) for each part, giving the OEM a single consistent quality baseline.
- 3
Validated the process and set up a Kanban replenishment schedule to smooth delivery.
- 4
Standardised passivation and finishing for medical use across the family.
Quality & inspection
Every part is CMM-verified to its drawing with documented inspection, under an ISO 13485 quality system with full lot traceability.