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ISO 13485

Last publication: 10/02/2017

More information on medical devices and the ISO 13485 standard

What is a medical device?

A medical device is a product to be used on people for diagnostic, preventive, control and treatment purposes, to alleviate illness, injury or disability. The main action of a medical device is not achieved by pharmacological or immunological means nor by metabolism. It is essentially a mechanical action.

Medical devices are subject to classification (I, IIa, 11b and III) according to the location of the action, the duration of the action and the dangerousness of the product. To receive market authorisation, the devices must bear the CE stamp attesting to the product's compliance with regulatory requirements.

The ISO 13485 standard

The exact title of the standard is: Medical devices - Quality management systems - Requirements for regulatory purposes.

It can only been granted after assessment and analysis of the different systems and organisations:

  • Quality management system
  • Management responsibility
  • Resource management
  • Product realisation

This certification therefore represents recognition of the complete development and effectiveness of the quality management system in place at Laboratoires Arkopharma. It strengthens the image of the Group on the international stage and demonstrates its desire to develop within a framework of continuous progress, to better meet consumer expectations.

Iso 13485 certification

The ISO 13485 certification