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Medical Devices

The Medical Devices division covers the development, approval and monitoring of medical devices in accordance with the applicable regulatory requirements. Our team provides support in implementing MDR requirements and documenting technical documentation. 

Medical Devices

  • Strategic consulting for the development and maintenance of medical devices

  • Support in the preparation of the Technical Documentation (TD), classification and CE marking of medical devices

  • Strategic and regulatory advice for importers and distributors of medical devices

  • Compliance with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

  • Support with actor and product registration in EUDAMED and Austrian Registry of medical devices

  • Regulatory guidance on labelling compliance of packaging materials and user manuals for the Austrian market

  • Review of promotional material

  • Marketing of medical devices

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