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Quality & Certifications

Certifications

Audited annually, documented per batch

Certificate of registration

ISO 9001

Design, manufacture and quality management of precision instruments.

Certified · audited annually

CE / EU MDR

Class I reusable instruments under EU 2017/745.

Declared · technical file held

US FDA

Establishment registration for export to the United States.

Registered

ASTM A967

Chemical passivation and corrosion resistance testing.

Compliant

Inspection

Results are recorded on an inspection sheet that travels with the carton. Copies are kept for ten years and available on request.

Material

Mill certificate verified; heat number logged against the batch.

Hardness

Rockwell hardness sampled after heat treatment against the pattern’s band.

Dimensions

Length, jaw and tip geometry checked against the controlled drawing.

Function

Closure, ratchet, spring tension and cutting performance tested by hand.

Corrosion

Passivation to ASTM A967, verified with boil and copper-sulphate tests.

Finish & marking

Surface finish, laser marking legibility and UDI codes inspected.

Batch inspection sheet

Mill test certificate

Declaration of conformity

Certificate of origin