Standards
Qualitywithout exception.
Every instrument is traceable from mill certificate to sealed box, made under certified medical-device quality management.
Standards
Certified,
four ways.
ISO 13485
Medical devices — quality management systems
CERT · 24
CE Mark
European Conformity, Class I & IIa instruments
CERT · 24
FDA Listed
US Food and Drug Administration facility registration
CERT · 24
ISO 9001
Quality management — international standard
CERT · 24
Inspection timeline — bar to box
Stage 01
Raw material audit
Every steel bar traced to mill certificate.
Stage 02
Forge & profile
Drop-forged, ground, and shaped to spec.
Stage 03
Heat treatment
Vacuum hardened for edge memory.
Stage 04
Hand polish
Six polishing stages by a master craftsman.
Stage 05
Passivation
Chemical passivation for corrosion resistance.
Stage 06
Final inspection
Signed, serialized, sealed.
Details
Quiet answers
to loud questions.
Yes. We manufacture under your brand — engraving, packaging, catalogue, and quality documentation. Minimums start at 250 pieces per SKU.