Manufacturing & Assembly Expertise

🔹 Controlled Environment Production

• We manufacture and assemble advanced medical devices in a fully controlled cleanroom environment (ISO 5 & ISO 7).

• Our facilities and processes are suited for high-precision, high-quality medical products requiring regulatory compliance.

🔹 Industrialization Support

We guide your project from design to scalable production :

✔ Design for Manufacturing

• We review and optimize design early to ensure manufacturability and cost efficiency.

✔ Design Verification & Validation

• We establish test protocols, carry out validation, and produce detailed reports with custom test benches.

✔ Production Transfer

• We begin with small batch manufacturing and scale up to larger volumes using repeatable and controlled processes.

✔ Process Validation & Documentation

• We implement process validation (IQ/OQ/PQ) and compile full manufacturing documentation (DMR) including supplier qualification, inspection instructions, and maintenance plans.

🔹 Comprehensive Manufacturing Capabilities

We support all stages of production for medical devices including:

✔ Proof of concept (POC)
✔ Prototypes
✔ Pre-series & validation batches
✔ Series production

🔹 Core Production Processes

We implement a broad range of specialized manufacturing techniques :

Material & Component Processing

• Silicone processing (injection, overmolding, bonding)

• Epoxy resin casting

• Nitinol and plastic heat treatment

• Surface activation (plasma)

• Polishing (optical fiber, silicone)

Joining & Assembly

• 5-axis laser welding in cleanrooms

• Electronic board and micromechanical assembly

• Connector integration and adhesive micro-assembly

• Leak testing and quality control benches

Marking & Packaging

• Laser marking and UDI traceability

• Blister packaging and ultrasonic cleaning

Additional Services

• Metallographic inspection

• Accelerated aging tests

• Micro-welding and humidity-controlled electronics assembly