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.
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.
