Product portfolio

Medical Devices

Medical Devices

The medical 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 putting devices regulated by the relevant EU regulations (medical devices, in-vitro diagnostics) into circulation. 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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The qualityaustria bonus system includes bonuses for system and product certification and is being updated every year. We are happy to provide you with more detailed information regarding your possible savings – please do not hesitate to contact us directly for a personal offer.

Our experts

Impartial. Competent. Trustworthy.

Network partner

Mr. Andreas Aichinger, MSc

Network partner, Product Expert Trainings Medical devices

Team

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

Ms. Ingrid Blaimauer

Business Development Medical devices ISO 13485 (QMD Services GmbH for Quality Austria)

+43 732 34 23 22