ISO 13485 for the medical device industry

The ISO 13485 standard defines requirements for a quality management system for manufacturers of medical devices.

The ISO 13485 standard is based on the ISO 9001:2000/2008 structure with additional requirements for the medical industry. The current 2016 version of the ISO 13485 standard does not yet follow the HLS (High-Level Structure).  Medical devices may only be sold by the manufacturer if they bear a CE mark. This is described in European directives for medical devices (MDD&MDR/AIMD/IVD&IVDR). These directives lay down requirements for a quality system for manufacturers of medical devices. The EN-ISO 13485 is a harmonized standard for the EU regulations concerning medical devices. This means that having an EN-ISO 13485 quality system assumes compliance with the quality system requirements as outlined in these EU directives.

The basis for applying a CE mark is in many cases, a quality system in compliance with ISO 13485, and for example, the medical devices directive (MDD/93/42/EC).

You will find more specific information on ISO 13485 on our website.
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