Medical Device Assembly and Packaging
Streamline Complex Assembly & Packaging With Scalable Solutions
Managing fragmented supply chains, complying with evolving global regulations, and ramping production without yield loss are critical challenges facing MedTech innovators. Viant eliminates operational risk by uniting device assembly, sterile barrier packaging, process validation, sterilization coordination, and global fulfillment under a single ISO 13485-certified quality management system.
From early-stage prototyping to full-scale commercial manufacturing, our engineering-driven approach delivers line repeatability, verified compliance, and market speed for critical Class I, II, and III medical devices.
Medical Device Assembly Services
Whether requiring intricate manual execution or high-speed automated assembly lines, Viant offers scalable infrastructure and engineering expertise tailored to your production volume.
Hands-On Precision, Built to Scale
Intricate medical devices often demand operator expertise that automated machinery cannot replicate. Viant combines specialized operator dexterity with rigid process controls to guarantee product integrity.
- Ultrasonic, spin, RF, and induction welding
- Metal and polymer laser welding
- UV/adhesive bonding, solvent bonding, and heat staking
- Precision micro-soldering and thermal impulse sealing
- In-line pressure decay and hermetic leak testing
- Electrical continuity, tensile, and functional testing
- High-magnification vision-assisted inspection
Targeted Automation with Operator Oversight
Semi-automated assembly bridges early prototyping and full production. By automating repetitive steps while retaining skilled oversight, Viant optimizes throughput and reduces labor costs without over-engineering.
- Custom equipment design and tooling build in-house
- Cellular stations designed for stepwise program growth
- PLC-driven process monitoring and torque verification
- Integrated 3-6 axis robotics for sub-component positioning
High-Speed Commercial Volume Production
When commercial demand calls for multi-million unit yields, Viant deploys fully automated production lines engineered for continuous operation, low cycle times, and zero-defect quality control.
- 100% in-line vision inspection and optical sorting
- Press-side automation and robotic end-of-arm tooling
- Automated device feeding, placement, assembly, and kitting
- Continuous error-proofing (Poka-Yoke) integration
Controlled Environments for Contamination-Sensitive Devices
For critical surgical instruments, implants, and fluidic pathways, contamination risk is unacceptable. Viant operates certified cleanroom facilities globally to meet stringent bioburden requirements.
- ISO Class 7 (Class 10,000) and ISO Class 8 (Class 100,000) facilities
- Particulate control and environmental microbiological monitoring
- Automated & manual assembly inside cleanroom boundaries
- Seamless transition to sterile barrier pouching and rigid tray sealing
Sterile Barrier Packaging & Process Validation
Medical device packaging must safeguard sterility throughout transportation and shelf life. Viant offers complete packaging system design, material selection, and rigorous validation protocol execution.
Packaging Design & Prototyping
Custom design of thermoformed rigid trays, flexible pouches, and protective outer cartons compliant with ISO 11607 Part 1. Rapid prototyping allows rapid design verification prior to production tooling launch.
Process Validation (ISO 11607 Part 2)
Complete Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for Form-Fill-Seal (FFS) lines, tray sealers, and pouch bar sealing machines.
Package Testing & Integrity Lab
Comprehensive in-house laboratory testing including Seal Peel Strength (ASTM F88), Dye Penetration Integrity (ASTM F1929), Bubble Emission (ASTM F2096), and Burst Testing (ASTM F2054).
Final Packaging, Kitting & UDI Serialization
Manual and automated component kitting, sterile packaging, barcode/GS1 label printing, Unique Device Identification (UDI) compliance, and custom retail-ready packaging.
Sterilization Consultation & Management
Navigating sterilization compatibility is essential to device efficacy and material integrity. Viant partners with certified contract sterilization facilities to manage validation protocols, bioburden testing, and turnaround schedules.
- Ethylene Oxide (EtO), Gamma Irradiation, and E-Beam coordination
- Sterilization validation protocol development (ISO 11135 / ISO 11137)
- Routine bioburden testing and dosage audit oversight
- Seamless schedule integration from cleanroom packout to sterilization exposure
Climate-Controlled Warehousing & Fulfillment
Viant extends your supply chain footprint through secure, climate-controlled warehousing dedicated to sterile medical device storage. Orders ship directly to distribution networks or clinical facilities with total lot traceability.
- Real-time inventory management with ERP system integration
- Serialization tracking and lot control compliance
- Customs documentation and global export fulfillment
- 30,000+ sq. ft. of dedicated medical warehouse capacity
Why Global MedTech OEMs Partner with Viant
With over three decades of MedTech manufacturing excellence, Viant combines technical depth, global risk mitigation, and unwavering quality compliance.
ISO 13485 & 14971
Certified quality management systems with risk management protocols integrated into every phase of device assembly and packaging.
Class I, II & III Experience
Proven execution across complex regulatory pathways, including PMA submissions and 510(k) cleared commercial devices.
DFM Engineering Depth
Dedicated design for manufacturability (DFM) engineers optimize assembly steps to lower unit costs and maximize manufacturing yields.
Lean Six Sigma Culture
Continuous process improvement, mistake-proofing methodologies, and advanced statistical process control (SPC) across all facilities.
Global Assembly Footprint
Scale your device production across strategically located facilities offering nearshore cost efficiency, US jurisdictional benefits, and robust risk management.
San Antonio, TX
Complex device assembly, cleanroom thermoforming, and finished device services.
Costa Rica
Cost-effective nearshore cleanroom assembly with direct proximity to US logistics networks.
Mexico
High-volume manual & automated device assembly and rapid fulfillment capacity.
Puerto Rico
US jurisdiction manufacturing operating under competitive labor rates and tax incentives.
Grand Rapids, MI
Dedicated Packaging Center of Excellence and complex finished device assembly.
Device Assembly & Packaging FAQs
Viant supports medical device projects across all stages of development—from early prototypes to high-volume commercial production. We assemble and package Class I, II, and III devices for surgical technologies, interventional cardiology, drug delivery systems, bioelectronics, bioprocessing, and patient care equipment.
All facilities operate under ISO 13485 and ISO 14971 certifications. Controlled operations utilize ISO Class 7 (Class 10,000) and ISO Class 8 (Class 100,000) cleanrooms equipped with bioburden monitoring, pressure-decay leak testing, and vision inspection systems.
We perform complete IQ/OQ/PQ process validation for form-fill-seal lines, pre-formed tray sealers, and pouch bar sealers in compliance with ISO 11607 Parts 1 & 2. Our package test lab executes ASTM tests for seal strength, dye penetration, burst testing, and stability.
Yes, our engagement models adapt to program maturity. We support low-volume clinical trial pilot runs through ViaLaunch™ program management and scale seamlessly into automated multi-million unit commercial production without needing supplier transfers.