Quality and compliance — Medlane surgical instruments

MEDLANE is a French company specializing in surgical instruments, based in Genas, near Lyon, France.

Certification

ISO 13485:2016

Headquarters

Genas, France

Instruments

Reusable

A certified quality management system

Medlane's quality management system is certified to ISO 13485:2016, the standard dedicated to medical devices.

Standard

ISO 13485:2016

Certification body

IMQ S.p.A.

Certificate no.

0270.2026

Valid until

Until 05/03/2029

Controlled design and production management

Medlane controls the design and production management of its reusable surgical instruments. This is carried out within the framework of the company's quality management system.

The stainless steels used to manufacture the instruments meet the requirements of EN ISO 7153-1:2016, with grades designated according to EN 10088-1:2014.

Traceability and marking

Instrument marking is performed in-house by laser, using a thermal annealing process that marks without removing material and preserves the surface finish.

Each product is tracked by a record from incoming inspection through to stocking, and marking uses qualified parameters stored per product.

Quality & Regulatory Documentation

Go further: traceability, laser marking and DataMatrix identification