ISO 13485
[NEEDS INPUT] Certificate number, issuing body and expiry.
Quality system
Quality
Inspection happens after every stage, and every finished instrument is checked by hand before it is packed.
Quality system
Certificates buyers ask for.
Upload each certificate with its number, issuing body and expiry. Until then, nothing here is claimed.
CE marking (EU MDR)
[NEEDS INPUT] Device class and declaration of conformity.
FDA establishment registration
[NEEDS INPUT] Registration and listing numbers.
Material certificates
[NEEDS INPUT] Mill certificates for the steel grades you use.
Checks
What we test
Incoming material
Steel arrives with mill certificates and is checked for grade before forging.
Hardness
Samples from each heat-treatment batch are tested against the pattern specification.
Function
Scissors cut to the tip, forceps meet evenly, ratchets engage on every tooth, box locks move without play.
Corrosion resistance
Passivated instruments are tested for corrosion resistance by batch.
Visual inspection
Every piece is checked under magnification for burrs, pits, cracks and finish defects.
Traceability
Laser-marked codes and lot numbers link each instrument to its batch and material certificate.
Paperwork
Documents with every order
- Commercial invoice and packing list with codes and lots
- Material certificates on request
- Declaration of conformity where CE applies
- Instructions for use and reprocessing
- Certificate of origin
Request a quote
Send us your list.
Add patterns to the quote list, or send a tender list, drawing or sample. Every order is quoted individually: pattern, length, finish, marking and packing.
- Quoted per code: length, finish, marking, packing
- Marked samples before bulk
- Tender lists and custom patterns welcome