Services – Design and Manufacturing of Medical Devices2025-12-02T13:57:21+00:00

The services: from the idea

to the certified device

I servizi: dall’idea
al dispositivo certificato

La divisione di Progettazione e Device Manufacturing di MDE Srl trasforma
un’idea in un dispositivo medicale completo e pronto per la produzione.
Un team multidisciplinare di ingegneri, progettisti e tecnici affianca il cliente in ogni fase dello sviluppo,
dalla definizione del concept alla validazione secondo la norma ISO 13485 e il Regolamento MDR 2017/745.

La divisione di Progettazione e Device Manufacturing di MDE Srl trasforma un’idea in un dispositivo medicale completo e pronto per la produzione. Un team multidisciplinare di ingegneri, progettisti e tecnici affianca il cliente in ogni fase dello sviluppo, dalla definizione del concept alla validazione secondo la norma ISO 13485 e il Regolamento MDR 2017/745.

I servizi: dall’idea
al dispositivo certificato

The services: from the idea to the certified device

La divisione di Progettazione e Device Manufacturing di MDE Srl trasforma
un’idea in un dispositivo medicale completo e pronto per la produzione.
Un team multidisciplinare di ingegneri, progettisti e tecnici affianca il cliente in ogni fase dello sviluppo,
dalla definizione del concept alla validazione secondo la norma ISO 13485 e il Regolamento MDR 2017/745.

Full-cycle biomedical engineering

Designing a medical device requires integrated expertise in mechanics, electronics, materials, and industry regulations. MDE offers a structured process that allows for the development of functional, safe, and fully traceable solutions. The operating method involves constant dialogue with the client and the application of internationally recognized design standards. Each phase is documented, verified and subjected to metrological and functional checks.

Technical Area​

Our services

Design & Device
Manufacturing

From concept study to product validation, in an integrated and certified flow.

Medical tube
extrusions

Dedicated lines for micro-extrusion and high-precision multi-layer tubing.

medical
Balloons

Custom balloons with compliance and burst pressure control.

Braiding &
Moulding

Advanced techniques for reinforced catheters and components.

3D Moulding
Biomedical

Rapid prototyping and additive manufacturing for functional and pre-clinical tests.

News &
Articles

Updates, technical insights, and news from the biomedical world.

FAQ

Can I provide technical specifications or customer drawings?2025-11-25T10:35:46+00:00

Yes, we work on both internal projects and customer specifications, in compliance with confidentiality agreements.

Does MDE also design devices in-house?2025-11-25T10:35:07+00:00

Yes, MDE designs and manufactures medical devices in-house, ensuring full traceability and ISO 13485 compliance.

How long does the design phase last on average?2025-11-25T10:31:12+00:00

It depends on the complexity of the device: from a few weeks for simple components to several months for complex projects requiring regulatory validation.

Is it possible to test a prototype before production?2025-11-25T10:30:01+00:00

Yes, we create functional prototypes and pre-production runs to verify performance and compliance before final production.

What type of software does MDE use for design?2025-11-25T10:30:40+00:00

We use 3D CAD, FEM, and CFD software for modeling, simulation, and mechanical optimization of components.

Info

To learn

Recruitments
Jobs facilitated services in 25+ countries

Do you want to start a project with MDE?

Contact us for technical advice or
a visit to our laboratories.

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