Product portfolio

Medical Devices

Medical Devices

The medical device technology as well as the medical device sector show a high level of innovation. Hundreds of new products are approved weekly, so that existing laws and regulations appear in a new image and creative implementation strategies are required.

Certification acc. to ISO 13485

ISO 13485 provides an international Standard for enabling manufacturers of medical devices to evidence an effective quality management system. This Standard refers to all the organizations that are operating within the supply chain or are involved in placing devices on the market regulated by the relevant EU regulations (medical devices, in-vitro diagnostics). This standard represents the state of the art. Therefore, certification acc. to this Standard is substantial to manufacturers of medical devices in Europe and is also increasingly being required from their suppliers. The standard specifies requirements for all types of medical devices, which includes services and, according to MDR and IVDR, software. The devices range from sterile to non-sterile medical devices, invasive to non-invasive medical devices as well as non-active medical devices to active implants. >> Read on

Training and certification of persons

For further information about our international training and certification program visit this page.

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Our experts

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Network partner

Mr. Andreas Aichinger, MSc

Network partner, Product Expert Trainings Medical devices


ein quadratischer Ausschnitt in schwarz weiß vom Kopf von Ingrid Blaimauer der QMD für die Quality Austria

Ms. Ingrid Blaimauer

Product Manager Medical Devices (QMD Services GmbH for Quality Austria)

+43 732 34 23 22