QUALITY & CERTIFICATIONS

Built for
real clinical use

This is how we ensure that every instrument leaving OrvexaMed meets the standard — from the steel in the blade to the final inspection at the working end.

Materials & manufacturing

Our instruments are made from surgical steel, primarily AISI 420 and genuine Solingen steel. The material is chosen to retain edge and fit over a long service life and to withstand the autoclaving cycles used in real clinics. Each delivery is traceable to its manufacturing batch.

Quality control

Instruments are supplied from manufacturers with quality systems certified to ISO 13485 — the international standard for medical devices. Working ends are inspected manually under magnification before an order leaves us, not on a sampling basis but on every single instrument.

Sterilization & care

The instruments are designed for repeated autoclaving at 134 °C. For best longevity we recommend ultrasonic cleaning immediately after use, careful inspection of joints and edges, and instrument oil when needed. Detailed care instructions are included or available on request.

CE/MDR & product documentation

Where stated in the relevant product sheet, applicable instruments meet the requirements of the EU Medical Device Regulation (MDR). We make no blanket CE-marking claim across the full range — marking, classification and available documentation are stated per article. Contact us for the correct documentation for your procurement.

DOCUMENTS & PROCUREMENT

Need documentation for your procurement?

We are happy to assist with product sheets, material certificates and sterilization information per article. Contact us at support@orvexamed.com or +46 8 123 456 78.

CONTACT CLINIC SUPPORT