Quality and standards
What we can state today, how each instrument is checked, and where we are heading.
Certification status
Not yet certified. We do not currently hold ISO 13485, CE marking or FDA clearance, and our instruments are sold without third-party certification. Any certificate will be listed here, with its number, only once issued.
Our standard inspection process
- Incoming material checkSteel bar and sheet are checked against the supplier's documentation before use.
- Hardness checkHardened parts are tested for hardness after heat treatment.
- Dimensional and visual checkTips, beaks, edges and joints are checked for shape, alignment and surface finish.
- Function testRatchets, hinges and pliers are opened, closed and locked; edges are tested for cut.
- PassivationFinished instruments are passivated to clean the surface and support the protective oxide layer.
- Final clean and packInstruments are cleaned, dried, inspected once more and packed.
Material documentation
Mill or material certificates from our steel supplier are available on request with your quote or order.
Design references
We use these published standards as references when specifying materials and reprocessing guidance. Referencing a standard is not a claim of conformity or certification.
| ISO 7153-1 | Surgical instruments — Materials — Part 1: Metals. Lists stainless steels used for surgical and dental instruments. |
|---|---|
| ASTM F899 | Standard specification for wrought steels for surgical instruments. |
| ISO 17664 | Information to be supplied by the manufacturer for the processing of medical devices. |
Supplied non-sterile
Every instrument ships non-sterile. Remove any protective packaging, then clean, inspect and steam sterilize it before first use and between patients, following your clinic's protocol and your autoclave manufacturer's instructions.
Try before you commit
Paid samples are available, and the sample cost is credited against your first order. Sample policy
Quality roadmap
| ISO 13485 | Quality management system for medical devices — Planned |
|---|---|
| CE marking | For sale as a medical device in the EU — Planned |