Medical Device Assembly and Packaging
Streamline Complex Assembly and Packaging With Integrated, Scalable Solutions
Managing multiple suppliers, ensuring regulatory compliance, and scaling production without disruption—these challenges create risk and delay for MedTech innovators, regardless of size or maturity. Viant eliminates these obstacles by providing comprehensive assembly, packaging, sterilization, and fulfillment services under one roof, accelerating your path to market with the integration and global manufacturing capabilities medical devices demand.
Medical Device Assembly Services
From manual precision work to fully automated production lines, Viant delivers the assembly expertise and scalable infrastructure required to support your device program at every stage.
Hands-On Precision, Built to Scale
Complex medical devices often demand the kind of skilled assembly that no machine can replicate. Viant’s manual assembly capabilities combine operator precision with robust manufacturing systems—so you can ramp production without switching partners.
Assembly processes:
- Ultrasonic, spin, RF, and induction welding
- Metal and polymer laser welding
- UV/adhesive bonding, solvent bonding, and heat staking
- Sewing, soldering, and impulse sealing
Forming and cutting capabilities:
- RF/thermal tippling, punching, and dip molding
- Die cutting, pneumatic press cutting, and skiving
- Automated tube cutting and coiling
In-process and final verification:
- Pressure decay and hermetic leak testing
- Electrical, compression/tensile, and functional testing
- Vision-assisted inspection
Operator Control Where It Counts. Automation Where It Matters.
Semi-automated assembly gives you the precision of experienced operator oversight combined with targeted automation—improving repeatability, throughput, and cost efficiency without over-engineering your line.
Automation design and support:
- Onsite expertise across Viant’s global network to identify the right automation opportunities early
- Custom machinery design/build for flexible, semi-automated equipment with full supplier oversight to spec
Assembly configurations:
- Semi-automated systems and cellular manned stations for stepwise scaling
- Full automation spectrum from operator-assisted cells to hybrid semi-automated lines
Enabling technologies:
- Robust vision inspection systems for in-line quality control
- PLCs, 3–6 axis robotics, and end-of-arm tooling design/build
- Automated QC and vision-assisted inspection integrated into existing workflows
High-Volume Production. Precise. Repeatable. Verified.
When your device is ready to scale, Viant’s automated assembly capabilities deliver the consistency, inspection rigor, and cycle efficiency that high-volume sub- and full-device assembly production demands.
Automation capabilities:
- Fully automated and semi-automated systems with integrated vision inspection, PLCs, and robotics
- Custom tooling and end-of-arm tooling designed and built to your specifications
- Automated assembly and QC/inspection processes, including unattended metals manufacturing and press-side automation
Scale and throughput:
- Fully automated lines with integrated vision systems and robotic handling across Viant’s network
- Manufacturing automation that extends from sub-assemblies into packaging and labeling workflows
- High-speed packaging automation capabilities to support end-to-end line efficiency
Quality assurance:
- 100% in-line verification through automated inspection systems
- Automated quality control integrated throughout the assembly process
Controlled Environments for Contamination-Sensitive Devices
For devices where contamination risk cannot be compromised, Viant’s cleanroom assembly capabilities provide the controlled environments, validated processes, and compliance infrastructure to support compliant scale-up across your program.
Cleanroom environments:
- ISO Class 7 and Class 8 certified controlled environments across multiple Viant facilities
- Dedicated cleanroom and white room space, including Class 7 & 8 areas in the US and ISO Class 8 environments in Suzhou
- Both automated and manual assembly options available within controlled environments
Supported capabilities:
- Cleanroom sub- and full-device assemblies across surgical, interventional, drug delivery, and other contamination-sensitive clinical markets
- Sterile barrier packaging support aligned to ISO 11607 requirements
- Packaging development and validation capabilities integrated with assembly workflows
Documentation and compliance:
- Robust documentation and quality controls designed to support Class I, II, and III device programs
- ISO 13485 certified quality systems across all controlled environment operations
Packaging Design & Development
- Packaging for terminally sterilized medical devices (ISO 11607 Part 1)
- Prototype package systems for evaluation and testing
- Package design verification and stability testing to ensure compliance with internal and regulatory requirements
- Dedicated Packaging Center of Excellence in Grand Rapids, MI
Packaging Process Validation (ISO 11607 Part 2)
- Form-fill-seal (FFS) process for rigid and flexible films
- Tray sealing using pre-formed thermo-formed trays
- Bar sealing for pouches and flexible packaging
Package Test Lab Capabilities
- Package integrity and visual inspection
- Seal strength testing
- Dye penetration testing
- Burst and creep testing
- Material thickness measurement
Final Packaging and Kitting
- Final packaging & sterilization management
- Manual & automated kitting
- Labeling & printing (incl. serialization/UDI)
- Sterile barrier packaging
- Logistics & fulfillment / distribution support
Sterilization Consultation & Management
Every device presents unique sterilization challenges. Viant works with you to identify the optimal sterilization method for your product and manages the entire process with contract sterilization providers—ensuring validation, documentation, and regulatory compliance.
Services include:
- Managing contract sterilization providers (ETO, E-beam, Gamma)
- Performing sterilization validations and writing protocols
- Auditing sterilization suppliers for quality and compliance
- Coordinating sterilization cycles with production schedules
Warehousing and Order Fulfillment
Viant’s warehousing and fulfillment services extend your supply chain without the overhead. Our centrally located facility features more than 30,000 square feet of climate-controlled space dedicated to sterile device storage. Your customers place orders, and we ship directly—seamlessly.
Capabilities include:
- Real-time inventory traceability and forecasting
- System integration or custom-built inventory databases
- International shipping and customs documentation
- Specialized handling for unique device requirements
Why Partner With Viant for Assembly and Packaging?
Engineering That Solves Complex Assembly Challenges
Our engineers collaborate with yours to optimize manufacturability and solve assembly complexities before they reach the production floor. From DFM guidance to custom automation design, we accelerate development cycles and enable more sophisticated device designs.
Flexible Engagement Models Aligned to Your Program Stage
Whether you need early innovation support, NPI/launch partnership, component manufacturing, finished device assembly, or sustained manufacturing—our service approach adapts to your goals. Dedicated program management ensures proactive communication and seamless execution.
Global Manufacturing Network That Scales With Your Device
25+ locations worldwide with consistent quality standards across all sites. Our strategically positioned facilities—including low-cost geographies in China, Costa Rica, Mexico, and Puerto Rico—enable you to scale production without switching partners while maintaining cleanroom environments and regulatory compliance.
Quality Systems Built for Medical Device Assembly
ISO 13485 certified with Class 7 & 8 controlled environments designed for device assembly and packaging. Our Lean Six Sigma programs, vision inspection systems, and comprehensive testing protocols ensure every assembled device meets regulatory requirements and performs reliably.
Proven Expertise Across Complex Medical Devices
Over 30 Years of Manufacturing Excellence
Viant is an ISO-certified medical device design & manufacturing partner with deep expertise across critical device categories. Our quality systems, controlled environments, and global footprint support MedTech OEMs and emerging innovators from early development through commercial launch.
Quality systems include:
- ISO 13485 & 14971 certified for quality management and risk management
- Dedicated cleanroom and white room space with Class 7 & 8 controlled environments
- Expertise in sterile barrier packaging (ISO 11607)
- Class I, II, and III devices, including PMA submissions
- Mature Lean Six Sigma program driving continuous improvement
- Multiple locations in the US and Europe + 4 low-cost geographies
Global Manufacturing Network
Leverage Viant’s strategically located facilities to optimize costs, reduce lead times, and ensure supply continuity. Our cost-effective manufacturing sites deliver the same quality standards and regulatory compliance as our US and European operations.
READY TO PARTNER?
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Medical Device Assembly & packaging FAQs
What type of projects do you work on?
Viant supports medical device projects across all stages of development—from early-stage prototypes to high-volume commercial production. We work with Class I, II, and III devices across multiple clinical markets including surgical technologies, interventional devices, drug delivery systems, diagnostics, and patient monitoring equipment. Our capabilities span component fabrication, complex assembly, packaging, sterilization management, and fulfillment services.
How do you maintain the quality of manufactured medical devices?
Quality is maintained through ISO 13485 and ISO 14971 certifications, Class 7 & 8 controlled environments, and a mature Lean Six Sigma program. We utilize robust vision inspection systems, comprehensive testing protocols—including pressure decay leak testing, hermetic leak testing, and functional testing—and rigorous documentation processes. Our experienced engineers apply the highest industry standards throughout the manufacturing process to ensure consistent, reliable performance.
Do you work with companies of all sizes?
Yes, Viant partners with medical device companies of all sizes—from early-stage startups to established OEMs. Our flexible engagement models and scalable manufacturing network allow us to support low-volume prototype runs through high-volume commercial production. As a vertically integrated partner, we grow with you, eliminating the need to transfer to a new supplier as your business scales.
How much does medical device assembly and packaging cost?
Yes, Viant partners with medical device companies of all sizes—from early-stage startups to established OEMs. Our flexible engagement models and scalable manufacturing network allow us to support low-volume prototype runs through high-volume commercial production. As a vertically integrated partner, we grow with you, eliminating the need to transfer to a new supplier as your business scales.