Surgical Star manufactures under the certifications your regulatory file depends on: ISO 13485 quality management, CE marking under EU MDR 2017/745, and US FDA establishment registration. Instruments are forged from German-grade stainless steel to ASTM F899.
Our Certifications & Registrations
| ISO 13485 | Medical-device quality management system |
|---|---|
| ISO 9001 | General quality management |
| CE / EU MDR 2017/745 | European market compliance |
| US FDA | Establishment registration; 510(k) support where required |
| ASTM F899 | Stainless steel for surgical instruments |
| Health Canada / TGA | MDEL and TGA documentation prepared per market |
Documentation We Provide
Certificates of conformity, ISO certificates and material certificates for the specific steel used in your order are supplied on request. Because we control forging through finishing in-house, the traceability behind every certificate is genuine.
Frequently Asked Questions
What certifications do you hold?
ISO 13485 quality management, CE marking under EU MDR 2017/745, and US FDA establishment registration, with certificates supplied on request.
What is your MOQ?
Low and new-brand-friendly, varying by instrument and finish — send your list for a realistic minimum and volume-tiered pricing.
Do you ship worldwide?
Yes — DDP, FOB or CIF to the USA, EU, UK, Canada, Australia and the Gulf, with documentation handled.
See Also
We prepare documentation matched to the USA, EU, UK, Canada, Australia and the Gulf.
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