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Device development: innovation and compliance with standards

Innovative and standards-compliant device development for medical technology: At Grossenbacher Systeme, we combine state-of-the-art technologies with a systematic development process to create safe, regulatory-compliant medical devices.

Grossenbacher Systeme AG
St. Gallen, Switzerland

At Grossenbacher Systeme, innovation and compliance with standards are at the heart of our device development for medical electronics. Our holistic approach combines innovation with a systematic development process, including the necessary documentation, to create safe and regulatory-compliant products. With our experienced team on site and within the group, we implement customized solutions that meet the high requirements of medical technology.

  • Holistic development process according to the V-model and/or agile methodology
  • Individual device development including approval according to MDR, FDA, and other standards, as well as support in hardware and software development and mechanical design
  • Expertise in cyber security – guaranteed secure products throughout the entire product life cycle
  • Consideration of relevant approval standards: EN 60601, ISO 13485, MDR, FDA guidelines.
  • Ensuring regulatory compliance for products up to class IIb for successful market launch.

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Afrim Musliu

Afrim Musliu

Sales Engineer

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