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Home / All / Material, Quality & Business Compliance / Do you hold ISO 13485 for Medical & Aesthetic components?
Do you hold ISO 13485 for Medical & Aesthetic components?
Straight answer
LusterControl is ISO 9001 certified, ISO 13485 completed, IATF 16949 applying. If your Medical & Aesthetic surgical handle & implant clip 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.
White-label oem and reliable re-export lead times.
Are you looking for a reliable manufacturer?
We can quickly provide customers with market analysis, technical support and customized services.From prototyping to production, our production sites can handle all your manufacturing projects.
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