ISO 13485: 2003 for the medical device industry

The ISO 13485: 2003 standard defines requirements for a quality management system for manufacturers of medical devices.

The ISO 13485 standard is based on ISO9001 format with additional requirements for the medical industry. 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/AIMD/IVD). These directives lay down requirements to a quality system for manufacturers of medical devices. ISO13485 is a harmonized standard for the EU regulations concerning medical devices. This means that having an ISO13485 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 ISO13485, and for example, the medical devices directive (MDD/93/42/EC).

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