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Do you hold ISO 13485 for Tooling & Mold components?
Straight answer
LusterControl is ISO 9001 certified, ISO 13485 completed, IATF 16949 applying. If your Tooling & Mold core pin & ejector is a regulated medical device, ISO 13485 is the baseline buyers must see — we hold it and can show the certificate.
What the cert buys you
- Documented control of special characteristics.
- Traceable lots and calibrated measurement.
- Auditable records if your Notified Body asks.
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