Electronic Medical Equipment

We translate your ideas into marketable medical devices ready for the healthcare industry.

From Concept…
Our multi-disciplined teams  are composed of experienced engineers focused on listening and understanding your needs in order to deliver a medical system that fits the market expectation.

To Prototype
A dedicated prototyping process combined with strong vendor relationships accelerate time to market for the first functional prototypes.  As an ISO13485 certified company, the design and manufacturing processes are integrated in our quality management system, also complying with these standards:

• Directive 93/42/EEC
• Norm IEC 60601
• 21CFR 820 (FDA regulation)

To Production
Customers benefit from our significant experience in medical device industrialization, our teams work:

• To apply proven manufacturing processes
• To increase the efficiency through Design for Manufacturing (DFM) approach
• To guarantee a world class quality level

Medical Device Project Management
A team is created with specific competences to fulfill your project requirements with a focus on the following:

• Project flow control sustained by Design Review with customer
• Customer reporting and product validation
• Subcontractor control and monitoring
• Interfacing with customers and regulatory bodies
• Design History File management