Every instrument leaves with a paper trail.
Material certificates, in-process inspection records and final AQL audits are held for every batch we ship — and available to you on request.
Current approvals and registrations
Certificates are issued in our legal entity name, Mediyuga Surgical Pvt. Ltd. Copies are available below; originals are provided on request for tender submissions.
ISO 13485:2016
Design, manufacture and supply of reusable surgical instruments. Issued by TÜV SÜD South Asia.
CE Marking — EU MDR
Class I reusable surgical instruments under Regulation (EU) 2017/745, with Annex IV declaration of conformity.
US FDA Establishment
Registered device manufacturer and exporter; Class I exempt instruments listed by product code.
ISO 9001:2015
General quality management certification covering the whole manufacturing operation.
Seven checkpoints between steel and sterile pack
Every steel consignment is checked against its mill test certificate for grade, heat number and chemistry before it enters the shop floor.
Hardness and grain structure are verified per forging lot after quenching and tempering; out-of-band lots are quarantined.
Working length, jaw alignment, ratchet pitch and tip geometry measured against the drawing with calibrated gauges.
Rockwell C testing on sampled units from each lot, with values recorded against the pattern specification.
Satin or mirror finish inspected under magnification; passivation confirmed by boil test for corrosion resistance.
Each instrument is cycled by hand — scissors cut test, forceps closure, ratchet engagement, retractor spring return.
Independent QA audit to AQL 0.65 before laser marking, labelling and release to packing.
From heat number to hospital
What we test against
| Parameter | Standard | Method |
|---|---|---|
| Material grade | ASTM F899 / AISI 420, 316L | Mill test certificate + spectro check |
| Corrosion resistance | ISO 13402 | Boil and steam exposure test |
| Hardness | Pattern spec (HRC 48–56) | Rockwell C, sampled per lot |
| Marking & nomenclature | ISO 7153-1 | Laser etch, legibility after 100 cycles |
| Sterilization | ISO 17665-1 | Autoclave validation to 134 °C |
| Packaging | ISO 11607-1 | Seal integrity and transit testing |
Regulatory questions we get asked
Are the instruments supplied sterile?
Can you support our regulatory filing in a new market?
How long are batch records kept?
Do you accept customer-witnessed inspection?
What happens if an instrument fails in service?
Need documentation for a tender?
Tell us which certificates and declarations the submission needs and we’ll send the current signed copies.
