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Engineer inspecting a surgical light assembly at a workbench, with technical drawings and a CAD model of the light behind him

Quality management

Quality is our priority.

Continually improving medical procedures through product innovations, comprehensive services, certifications and training programmes.

Commitment

Quality is our priority. IG Medical states its mission as continually improving medical procedures through product innovations, comprehensive services, certifications and training programmes.

Manufacturing is carried out as a dedicated medical device manufacturer, continuously seeking improvements and technological advancements.

Certifications & documentation

  • Quality Management System

    ISO 13485

    The quality management system for medical devices that IG Medical works to. The current certificate is supplied with the documentation pack on request.

  • 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.

Regulatory documentation — declarations of conformity, quality management certificates and product-specific technical files — is issued directly by IG Medical for the market and product in question. Contact our team with the device and destination country and the current documentation will be provided.

Request documentation

Need regulatory documentation?

Tell us the device and the destination market, and our team will send the applicable documentation.

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