Quality and certification
Instruments are only as good as the steel and the inspection behind them. This page sets out what we are certified to, what our materials conform to, and what documentation we keep.
ISO 13485:2016
Our quality management system for medical devices is certified to ISO 13485:2016 by Staunchly Management & System Services, an EGAC-accredited certification body and IAF MLA member.
Certificate PK59333H covers the manufacture and export of dental instruments, orthopaedic instruments and implants, electrosurgical instruments, general surgical instruments, and neuro and spine instruments and implants. A copy of the certificate is available to customers on request.
| Standard | ISO 13485:2016 Medical devices — quality management systems |
|---|---|
| Certificate | PK59333H |
| Certification body | Staunchly Management & System Services Ltd |
| Registered since | March 2025 |
| Also applied | ISO 9001:2015, ISO 14971:2019, cGMP |
Materials
We buy certified bar and sheet and keep the mill certificates with each batch.
| Surgical and dental instruments | Stainless steel to ASTM F899-20 and ISO 7153-1 (martensitic grades for cutting edges, austenitic for non-cutting) |
|---|---|
| Beauty tools | 420 and 440C stainless, heat-treated |
| Implants — stainless | Implant-grade stainless to ASTM F899 / ISO 7153-1 |
| Implants — titanium | Commercially pure titanium to ISO 5832-2 |
| Tungsten carbide | Brazed inserts on TC needle holders and scissors |
Implant documentation
For bone plates and screws we maintain a technical file prepared to the European Medical Device Directive 93/42/EEC and ISO 13485, including:
- Technical file with device description, intended use, classification (Class IIb, rule 8) and manufacturing specifications
- Risk analysis and risk management report to ISO 14971:2019
- Biocompatibility evaluation to ISO 10993-1, covering cytotoxicity, sensitisation, systemic toxicity and blood interaction
- General safety and performance requirements checklist
- EC declaration of conformity, signed by the manufacturer
Devices are supplied non-sterile and are single use. Distributors placing devices on a regulated market are responsible for registration in that market; we supply the documentation to support it.
Inspection
Every batch passes three inspection points.
| Receiving | Material certificates checked against the order; hardness and dimensions sampled |
|---|---|
| In process | Jaw alignment, ratchet action, cutting test and finish checked after grinding and after heat treatment |
| Final | 100% visual and functional inspection, passivation check, boil test for corrosion, marking verified against the approved sample |
Need a price on this range?
Send catalogue codes, a drawing or a reference sample. We reply with pricing, MOQ and lead time within two business days.