Medical Technology

We develop custom hardware solutions for medical technology applications—from concept to integration.

• Development of complex electronic systems, including sensors and interfaces
• Integration and customization of firmware, as well as product maintenance
• Qualification and failure analysis under real-world conditions
• Development in accordance with ISO 13485

We support mechanical product development from the concept phase through to production readiness and ensure functional and manufacturable solutions.

• Design of components and assemblies, as well as prototype construction
• Conducting simulations and calculations to ensure functionality and proper design
• Optimization of tolerances, materials, and manufacturing concepts
• Technical documentation in accordance with MDR and ISO 13485

We conduct comprehensive testing of medical technology systems—from individual components to the entire system.

• Requirement and verification engineering
• Manual and automated testing, including endurance testing and software testing
• System qualification and ensuring quality and process stability
• Support for international regulatory approvals (e.g., EU, U.S., China)

Our testing laboratory ensures reliable testing and validation for safe medical devices that comply with standards.

• Physical testing and reliability testing in an accredited environment
• Qualification of devices and systems in accordance with DQ, IQ, OQ, and PQ
• Development, verification, and validation of test methods
• Statistical analysis and evaluation of measurement results

We support you in implementing regulatory requirements throughout the entire product lifecycle.

• Preparation and adaptation of technical documentation in accordance with EU regulations and the MDR
• Conducting risk analyses in accordance with ISO 14971, as well as audits and GAP analyses
• Support for national and international approval processes
• Establishment and further development of quality management systems

We develop software solutions for medical applications—compliant with standards and user-centric.

• Development of software, firmware, and apps for various platforms
• Implementation in accordance with IEC 62304 and ISO 13485
• UI/UX development with a focus on usability requirements
• Maintenance, support, and further development of existing applications

Our testing laboratory offers certified testing services that meet the highest quality standards.

• Testing in accordance with ISO/IEC 17025 for medical devices
• Conducting conformity assessments and accredited testing procedures
• Quality assurance through audits (e.g., DAkkS, ZLG)
• Reliable and traceable test results

We develop efficient production solutions for medical devices.

• Design and implementation of assembly and filling systems, including those for cleanroom environments
• Integration of inspection stations and end-of-line test systems
• Combination of mechanical, electronic, and image processing technologies
• Support for the development and optimization of manufacturing processes