Table of contents
Full-Cycle Biomedical Engineering
MDE’s Design & Device Manufacturing division is the connection point between research, technology, and production. Every device is developed through an integrated process that ensures reliability, safety, and regulatory compliance. From concept definition to the finished product, every phase is supervised by a multidisciplinary team of engineers, technicians, and quality specialists. The result: customized medical devices that are traceable and fully compliant with UNI EN ISO 13485:2016 and MDR 2017/745 standards.
A Structured and Certified Process
Every project follows a precise operational flow, developed to reduce time and risks of non-compliance. The main phases:
This method ensures optimized timelines, controlled costs, and regulatory compliance in every phase.
Co-design: Design as Collaboration
MDE adopts a co-design approach that actively involves the client in the development process. Technical specifications are analyzed together, digitally simulated, and optimized to ensure maximum clinical and production yield.
“We design devices that arise from constant technical dialogue, where every detail is verified, measured, and improved.” — MDE Design Team
This direct collaboration allows for the development of customized solutions, reducing industrialization times and maximizing safety.
Research Laboratories and Technologies
The MDE R&D laboratory is equipped with the latest generation of instruments for testing, analysis, and prototyping. Main equipment:
All tests are performed in controlled ISO 7 and ISO 8 environments, with digital recording of parameters.
Do you have an idea or technology to develop? Collaborate with MDE’s R&D department to turn research into a certified device.
Contact the MDE R&D team.
From Design to Production
Once the design is validated, MDE proceeds with series production within its ISO 7–8 certified cleanrooms, where every process parameter is digitally monitored. The direct connection between design and production allows for perfect continuity between the CAD model and the physical result, minimizing dimensional variations. All devices undergo metrological checks and mechanical testing before delivery, with complete lot traceability and an updated Device History Record (DHR).
Compliance and Technical Documentation
Every MDE project is accompanied by complete documentation, verified according to international standards. Documents provided:
This approach allows clients to obtain MDR-ready devices, with reduced time and maximum reliability.
In summary
Biomedical design at MDE is a scientific, precise, and measurable process. Every device is born from an idea and becomes reality thanks to a structured method, advanced digital tools, and an integrated vision of quality and innovation.
