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Regulatory information

Certifications

Quality marks and regulatory information for IG Medical devices, presented for identification.

Certifications & documentation

  • ISO 13485 — Quality Management System
    Quality Management System

    ISO 13485

    IG Medical works to a quality management system for medical devices in accordance with ISO 13485.

  • CE marking — Affixed to the device
    Affixed to the device

    CE marking

    Affixed by IG Medical to indicate that a device conforms to the applicable European requirements. The declaration supporting it is issued per device and market.

  • Certificate of Free Sale — For export and registration
    For export and registration

    Certificate of Free Sale

    Confirms that a device is freely sold in its country of origin — commonly required by importing authorities during product registration.

  • EU Declaration of Conformity — Per device and market
    Per device and market

    EU Declaration of Conformity

    Issued by IG Medical for the device and destination market in question, together with the applicable technical documentation.

Medical-device compliance information must be verified against the applicable, current documentation for each product. CE marking and quality-management information are presented for identification, without publishing certificates.

Request Information

Questions about a device or a market?

Tell us the device and the destination market, and our team will advise you.

Request Information+49 421 8478 8804

IG Medical GmbH · Schongauerstr. 5, 28219 Bremen, Germany