Medical Device & Implant Assembly Services
Streamline your production with our FDA-registered services for medical device assembly, packaging, and sterilization.
Accelerate your product launch with FDA-registered, ISO 13485-certified manufacturing. From cleanroom assembly to packaging, labeling, and sterilization—LSO delivers compliant, turnkey solutions for medical devices and implants.
End-to-End Solutions forMedical Device & Implant Manufacturing
Bringing life-saving medical devices and implants to market requires precision, compliance, and efficiency. At Life Science Outsourcing (LSO), we offer comprehensive contract manufacturing services designed to streamline production, ensure regulatory compliance, and accelerate commercialization for medical device manufacturers.
As an FDA-registered, ISO 13485-certified contract manufacturer, we specialize in assembly, packaging, sterilization, labeling, and supply chain management—all under one roof. Whether you’re developing orthopedic implants, cardiovascular devices, or minimally invasive surgical tools, our scalable, flexible solutions help bring your products to market faster and more efficiently.
Comprehensive Medical Device & Implant Services
Medical Device Assembly
From simple subassemblies to complex medical implants, our cleanroom assembly services meet the highest quality and regulatory standards.
We offer:
- Manual, semi-automated, and fully automated assembly
- Cleanroom assembly in ISO Class 5-8 environments
- Customized solutions for orthopedic implants, surgical instruments, and cardiovascular devices
Medical Device Packaging & Kitting
Ensure your devices are sterile, compliant, and market-ready with our custom packaging and kitting solutions. We specialize in:
- Sterile barrier packaging for implants and instruments
- Custom medical device kitting
- ISO 11607-compliant validation and testing
Complex Assembly for High-Precision Devices
Our complex assembly services are designed for medical devices that require:
- Multi-component integration
- Advanced adhesive bonding, welding, and encapsulation
- Precision manufacturing for neuromodulation, electrophysiology, and implantable devices
Medical Device Labeling & Compliance
Regulatory-compliant labeling is critical for traceability, UDI compliance, and patient safety. LSO offers:
- UDI-compliant labeling solutions
- Tamper-evident and specialty labels
- Full lot traceability and ERP-integrated tracking
Supply Chain Management for Medical Devices
We help you reduce risk, lower costs, and optimize supply chain efficiency with:
- Vendor management and component sourcing
- Just-in-time (JIT) inventory solutions
- Global logistics and distribution support
Medical Device Cleaning & Passivation
Ensure biocompatibility and long-term device integrity with our:
- Precision ultrasonic and aqueous cleaning
- Passivation of stainless steel and titanium implants
- Validated cleaning protocols for regulatory compliance
Why LSO?
- FDA-Registered, ISO 13485-Certified – Ensuring compliance with the highest industry standards
- End-to-End Manufacturing & Assembly – From prototyping to full-scale production
- Bicoastal & Nearshore Operations – Facilities in California, New Hampshire, and Costa Rica for cost-effective, scalable solutions
- Quick-Turn Services – Faster sterilization, validation, and lot release to accelerate market entry
- Proven Expertise in Medical Devices – Supporting orthopedics, neuromodulation, cardiovascular devices, and more
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica