- ISO 13485 & 9001 Certified, FDA Registered, Cleanroom Equipped -
Precision Plastic Components
Life-Saving Medical Devices
Why Leading MedTech Companies Choose SigmaPro
Unmatched Precision
Molding components with dimensional tolerances down to ±4 microns using advanced process control and metrology.
Regulatory Excellence
ISO 13485 and 9001 Certified, FDA Registered, and aligned with MDR requirements.
Cleanroom Manufacturing
Class 8 cleanroom molding, assembly, and packaging for medical and life science applications.
End-to-End Support
Design for Manufacturability (DFM), tooling, process validation, and scalable production.
Your Partner in High-Precision Medical Manufacturing
SigmaPro Molding specializes in the precision injection molding of complex medical components that demand accuracy, repeatability, and cleanliness. From early design collaboration through validated production, we deliver solutions for the world’s most trusted medical device manufacturers.
Our engineering and production teams leverage cutting-edge molding technology, in-process data monitoring, and ISO 13485-certified quality systems to meet micron-level requirements in high-volume production.
Focused on the Medical and Life Science Sectors
SigmaPro supports OEMs and Tier 1 suppliers in the design and production of precision plastic components used in medical technology, diagnostics, and drug delivery systems.
- Minimally Invasive Surgical Devices
- Drug Delivery & Therapeutic Systems
- Diagnostic & Analytical Consumables
- Optical & Wearable Medical Assemblies
Each project is engineered with a focus on precision, biocompatibility, and validation for regulatory compliance.
Advanced Manufacturing, Proven Quality
Our facility integrates modern injection molding systems, robotics, and precision metrology for consistent, data-driven manufacturing. With in-house tooling maintenance, engineering support, and cleanroom operations, we maintain strict control over every aspect of production.
- Texas-based, 12,000 sq. ft. advanced molding center
- In-house CMM, optical inspection, and validation equipment
- Class 8 cleanroom for molding and assembly
- Real-time process data monitoring and traceability