01
Certificate of conformity
Confirms the order meets the agreed specification.
- Issued per order
- Signed by QC
- Matches your PO
Certified, traced, checked by hand.
Our quality system is built for the documentation your customers and regulators ask for — on every order.
CERTIFICATES
Audited systems, current certificates.
ISO 13485Quality management for medical devices.
ISO 9001Certified quality management system.
ISO 14001Environmental management system.
CEConformity with EU medical device requirements.
SA 8000Ethical and social accountability in the workplace.
Three checkpoints
Inspected at the door, on the line, before the box.
WITH EVERY SHIPMENT
Paperwork included.
Materials meet ASTM F899 and ISO 7153-1 for surgical stainless steel. Every batch is traceable back to the mill certificate.
02
Material test certificates
Mill certificates for the steel used in your batch.
- ASTM F899 grades
- Chemical composition
- Hardness results
03
Batch traceability
Lot codes marked on instruments and packaging.
- Laser-marked lot codes
- Codes on every label
- Traced to the mill
04
CE declaration of conformity
For shipments into EU and CE-accepting markets.
- EU market ready
- Supplied with shipment
- Available for tenders