Certified Design and Manufacturing of Medical Devices
MDE’s Design and Manufacturing division transforms ideas into production-ready medical devices. From concept studies to high-precision tubing extrusion and balloon manufacturing, the ISO 13485 certified team provides comprehensive engineering for complex biomedical components.
Biomedical Engineering: From Concept to Finished Product
Developing a medical device requires integrated expertise in mechanics, electronics, materials, and regulatory requirements. MDE offers a structured process that enables the development of functional, safe, and fully traceable solutions.
Comprehensive Technical Services
A multidisciplinary team of engineers, designers, and technicians supports customers at every stage of development. Internationally recognized design standards are applied, and every step is precisely documented and validated:
- Design & Device Manufacturing: Transformation of ideas into fully developed, production-ready medical devices.
- Medical Tube Extrusion: Dedicated lines for micro-extrusion and high-precision multi-layer tubing.
- Medical Balloons: Custom balloons with precise control of compliance and burst pressure.
- Braiding & Molding: Advanced techniques for reinforced catheters and complex biomedical components.
- Biomedical 3D Printing: Rapid prototyping for functional and pre-clinical tests as well as small series production.
Validation and Compliance
MDE operates according to strict quality standards to ensure compliance with ISO 13485 and the MDR Regulation 2017/745. Using modern software for 3D CAD, FEM (Finite Element Method), and CFD (Computational Fluid Dynamics), components are simulated and mechanically optimized as early as the design phase.
Visit MDE at MedtecLIVE 2026 to learn how our engineering and manufacturing partnerships can bring your projects to success—from the initial sketch to final cleanroom validation.
