Fremont, California

Injection Molding and Assembly for Performance-Critical Devices

Viant Fremont is known for supporting medical device programs that require precise molding, disciplined processes, and steady execution. The site has long served surgical, interventional, diagnostic, and laboratory technologies where part performance and consistency are non-negotiable.

The site centers on insert molding, overmolding, and high-temperature materials, produced across 30 presses operating 24/7 in cleanroom and controlled environments. Continuous monitoring and on-site tooling support help maintain process control and throughput.

Located next to Viant’s Fremont Design & Development center, it puts design engineers and the production floor within walking distance of each other. A molding or tooling issue can go straight back to the team that built the process, keeping the loop between a change and a validated fix short as a program scales toward higher volume.

Facility snapshot

Fremont At-A-Glance

Expertise: Complex injection molding, insert molding, overmolding, assembly, functional testing, and packaging support for surgical, interventional, diagnostic, and laboratory products
Known for: 24/7 molding performance across high-mix programs, strong responsiveness, and close integration with Viant’s Design & Development Center
Certifications: FDA Registered; ISO 13485 certified; cGMP compliant
Environment: 51,000 sq. ft. facility; 6,500 sq. ft. Class 8 cleanroom; 30 molding presses; tool room for mold repair and maintenance
Location: 45581 Northport Loop West
Fremont, CA 94538
United States

Core CapabilitiesOur ApproachWhat it Means For You
Molding & OvermoldingComplex, precision medical device injection molding using 30 presses (high-mix / low-volume), including horizontal and vertical presses, insert molding, overmolding, and high-temperature materials. Class 8 cleanroom and white-room molding support parts that must meet strict cleanliness and performance requirements.Reliable, repeatable molded components with the geometries, materials, and cleanliness levels your devices require without needing multiple molding suppliers.
Assembly & Finished Device ServicesSub-assembly and finished device assembly, including mechanical and electromechanical builds, microscope assembly, ultrasonic welding, heat staking and adhesive bonding, plus finished-goods assembly that can be sterile packed.A single partner to mold, assemble, and integrate components, reducing handoffs, logistics risk, and launch complexity.
Secondary Processes & MachiningFunctional testing, pad printing (multi-color), plasma treatment, and CNC machining of plastic components, supported by an onsite tool room for mold maintenance and repair.Components and assemblies leave Fremont ready for downstream integration, with tooling and processes kept in tune to protect quality and uptime.
Packaging & Sterilization SupportNon-sterile and sterile-barrier packaging (including tray sealing), plus an in-house packaging test lab for peel tests and dye-penetrant evaluations. Sterilization management supported through strong regional resources.Your packaging is developed and verified to protect product integrity with test data and sterilization coordination handled alongside manufacturing.
Quality, Regulatory & ComplianceFDA-registered, ISO 13485 certified, and cGMP-compliant with a proven track record of successful audits and a focus on building quality into the process.Audit-ready documentation, stable processes, and confidence that parts meet regulatory expectations for medical and pharma use.

Core Capabilities & Approach & Outcomes

Molding & Overmolding
Complex, precision medical device injection molding using 30 presses (high-mix / low-volume), including horizontal and vertical presses, insert molding, overmolding, and high-temperature materials. Class 8 cleanroom and white-room molding support parts that must meet strict cleanliness and performance requirements.
What it means for you:
Reliable, repeatable molded components with the geometries, materials, and cleanliness levels your devices require without needing multiple molding suppliers.
Assembly & Finished Device Services
Sub-assembly and finished device assembly, including mechanical and electromechanical builds, microscope assembly, ultrasonic welding, heat staking and adhesive bonding, plus finished-goods assembly that can be sterile packed.
What it means for you:
A single partner to mold, assemble, and integrate components, reducing handoffs, logistics risk, and launch complexity.
Secondary Processes & Machining
Functional testing, pad printing (multi-color), plasma treatment, and CNC machining of plastic components, supported by an onsite tool room for mold maintenance and repair.
What it means for you:
Components and assemblies leave Fremont ready for downstream integration, with tooling and processes kept in tune to protect quality and uptime.
Packaging & Sterilization Support
Non-sterile and sterile-barrier packaging (including tray sealing), plus an in-house packaging test lab for peel tests and dye-penetrant evaluations. Sterilization management supported through strong regional resources.
What it means for you:
Your packaging is developed and verified to protect product integrity with test data and sterilization coordination handled alongside manufacturing.
Quality, Regulatory & Compliance
FDA-registered, ISO 13485 certified, and cGMP-compliant with a proven track record of successful audits and a focus on building quality into the process.
What it means for you:
Audit-ready documentation, stable processes, and confidence that parts meet regulatory expectations for medical and pharma use.

Ready to discuss your project?

Manufacturing Capabilities

With an expansive global footprint, Viant offers unmatched manufacturing scale and speed. Our focused approach aligns your resources with our capabilities for maximum efficiency. Get expert advice on accelerating time to market, reducing lead times, mitigating validation risk, and ensuring product performance.