Our process begins with transforming surgical insights into actionable engineering direction. Whether you’re introducing a new product or enhancing an existing design, our cross-functional team of engineers collaborate with you to define key specifications, functional goals & design parameters. By aligning with your clinical goals & market expectations, we define precise performance criteria, anatomical fit & usability standards

Once the concept is finalized, we assess the technical, clinical, and regulatory feasibility of the design. This stage includes:

• Preliminary 3D modeling
• Material selection (e.g., SS316L, Titanium, PEEK, UHMWPE)
• Manufacturability and cost analysis
• Design input review based on ISO 13485 & MDR/FDA standards

We produce initial working models and functional prototypes using CNC machining, rapid prototyping, and 3D printing technologies. These help assess form, fit, and function before full-scale production.

Key activities include

• Design iteration and optimization
• Surgeon feedback integration
• Initial mechanical testing

Critical for safety and compliance, we perform rigorous testing and validation:

• Mechanical strength (ASTM/ISO standards)
• Biocompatibility (ISO 10993)
• Functional simulation and life cycle testing
• Documentation for CE/USFDA submission

We ensure every implant meets stringent performance and sterilization benchmarks.

A limited production batch is manufactured to validate:

• Process control and consistency
• Tooling and fixture performance
• In-line quality assurance (QA/QC)
• Packaging integrity and labelling verification

This step allows real-world assessment before scaling up.

Once validated, we initiate batch production with:

• CNC precision machining
• Surface treatments (passivation, anodizing, polishing)
• Laser marking
• In-house or third-party sterile packaging (EO/Gamma)
• Robust QA systems with documentation for each lot

Our facility adheres to ISO 13485 and Good Manufacturing Practices (GMP)

To ensure on-time delivery:

• Finished goods are stored in controlled environments
• Serialized inventory systems for traceability
• Global shipping support with compliant labeling
• Flexibility to support Just-in-Time (JIT) or blanket orders

It’s here! It’s finally time for the world to see your new Medical device implant or Instrument set. Whether you need help with inventory management or just-in-time shipments to expedite the fulfillment process, our team is here to guide you from start to finish.