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From Laboratory to Production Line

Every biomedical device starts with a material. In extrusion division, MDE works to transform the properties of medical-grade polymers into functional and clinically reliable solutions. Research, design, and production constantly communicate to ensure the perfect integration between material, process, and performance. The result is a controlled, traceable, and fully certified supply chain, from raw material selection to finished product validation.

Selected Medical-Grade Materials

MDE exclusively uses certified and traceable materials, compliant with ISO 10993 and MDR requirements. Every polymer is chosen based on the clinical application, biological compatibility, and sterilization requirements. Main materials used:

  • Pebax®, PA, PU, PP, PE, medical-grade PVC
  • Fluorinated polymers (FEP, PFA, PTFE) for chemical resistance and sterilizability
  • Medical silicone for soft or flexible applications
  • Radiopaque or transparent polymers for imaging and fluoroscopic visibility

Each material is internally validated through rheological, mechanical, and biological compatibility tests.

Advanced Production Technologies

MDE’s production lines integrate technologies that allow for the processing of complex materials with micrometric precision, in controlled ISO 7–8 environments. Main technologies used:

  • Medical extrusion of single and multi-layer tubing with in-line laser control
  • Braiding and reinforcement with fibers and metals for catheters and sheaths
  • Molding and over-molding for integrated components and connectors
  • Balloon forming with thermal control and calibrated pressure
  • Biomedical 3D printing for functional prototypes and small series
  • Polymeric compounding for the development of customized formulations

Cleanrooms and Environmental Control

Material quality is inextricably linked to environmental control. This is why MDE operates exclusively in certified ISO 7 and ISO 8 cleanrooms, where temperature, humidity, and particulate matter are constantly monitored.

“Precision comes from control. Every polymer, every micron of wall thickness is the result of a stable, repeatable, and documented process.” — MDE Technical Management

This guarantees the purity of components and the safety of devices intended for clinical use.

Do you want to manufacture biomedical components with advanced materials? Discover how MDE integrates medical-grade materials and proprietary technologies to ensure performance and traceability.

Contact the MDE R&D team.

Innovation and Material Sustainability

MDE’s material research also focuses on environmental sustainability and long-term safety. The main development directions include:

  • Medical-grade polymers and metals for the rapid production of customized components and prototypes
  • New cutting-edge devices in the cardiovascular field
  • Energy optimization of compounding and printing processes
  • LCA (Life Cycle Assessment) analysis for material impact evaluation

Compliance and Technical Documentation

Every MDE project is accompanied by complete documentation, verified according to international standards. Documents provided:

  • Material batch
  • Process parameters
  • Validation test results

This system ensures full traceability and compliance with the requirements of the MDR 2017/745. The combination of validated materials, cleanrooms, and advanced manufacturing technologies is the hallmark of excellence that sets MDE apart in the European biomedical sector.

In summary

MDE combines engineering expertise and materials research to create next-generation medical devices.

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