Accelerating Medical Innovation. Minimizing Risk.

Your R&D partner in cutting-edge medical technology: from concept sketch to **FDA-cleared device**.

Our Core R&D Disciplines

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Surgical Robotics

Expertise in precision mechanics, haptics, and motion control for minimally invasive procedures.

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In-Vitro Diagnostics (IVD)

Rapid prototyping and scaling of point-of-care testing devices and laboratory systems.

Our Four-Phase Path to Compliance

1

Discovery & Strategy

Feasibility studies, IP analysis, and user needs definition. Deliverable: Technical Spec Document.

2

Prototyping & DVT

CAD design, functional alpha prototyping, and rigorous design verification testing.

3

Validation & DHF

Full V&V testing, ISO 14971 Risk Management, and comprehensive Design History File (DHF) creation.

4

Regulatory & Launch

FDA 510(k)/PMA preparation, CE Mark strategy, and smooth transfer to scaled manufacturing.