Thermal and Pressure Precision
Balloon forming is a complex thermal and mechanical process. MDE uses latest-generation machinery with digital control of temperature, pressure, and the release phase, which are essential for achieving homogeneous walls and reproducible performance. This micrometric control ensures maximum clinical reliability of the device.
Materials and Types of Balloons
We develop balloons from highly selected medical-grade polymers, ideal for vascular, urological, and gastroenterological applications.
Types and Characteristics:
Our test
Quality Control and Testing
Every formed balloon undergoes rigorous testing to guarantee its clinical reliability:
Coating and Wall Uniformity Precision
The dipping process for manufacturing medical balloons requires extremely precise control of immersion parameters, polymer viscosity, and withdrawal timing. MDE uses automated systems with digital control of immersion speed, temperature, and polymer bath concentration, ensuring uniform wall thickness and defect-free surfaces. This precision ensures functional reliability and clinical safety.
Dipping
Materiali e Applicazioni dei Balloon per Dipping
We produce dipped balloons using carefully selected medical-grade polymer dispersions and solutions, ideal for catheters, dilation devices, and low-profile applications.
FAQ
Yes, each balloon is made to the customer’s specifications in terms of diameter, length, and compliance.
Each product is tested in a cleanroom with dimensional checks, burst pressures, and documented validations.
Yes, we offer full support for IQ/OQ/PQ and MDR 2017/745 documentation.
Pebax®, Nylon, PU, PET, and other medical-grade formulations, including co-extruded or reinforced ones.
