Medical Device Manufacturing That Scales With Your Success
FDA-registered contract manufacturer supporting 820+ successful device launches with ISO 13485 certified processes across assembly, packaging, sterilization, and fulfillment.
Proven Results Across 25+ Years
820+
Startup Launches
$4B+
Client Acquisition Value
125K+
Sq Ft Manufacturing
12
FDA Cleanrooms
End-to-End Medical Device Contract Manufacturing
Life Science Outsourcing provides comprehensive contract manufacturing services for medical device companies, from early-stage startups to established enterprises. Our FDA-registered facilities in California, New Hampshire, and Costa Rica deliver scalable solutions that grow with your business.
With ISO 13485 certification and expertise across assembly, packaging, sterilization, and distribution, we eliminate the complexity of bringing medical devices to market while ensuring regulatory compliance at every step.
Complete Manufacturing Capabilities Under One Roof
From prototype to commercial scale, we handle every aspect of medical device production
Assembly & Kitting
Precision assembly in Class 5-8 cleanrooms with documented procedures and full traceability
Packaging & Validation
ISO 11607 sterile barrier packaging with accelerated aging and transit validation
Sterilization Services
EtO, gamma, and steam sterilization with ISO 11135/11137/17665 validation protocols
Quality & Compliance
FDA 21 CFR 820 QSR compliance with lot genealogy and complete documentation
Global Distribution
Fulfillment and logistics services with temperature-controlled storage capabilities
Rapid Scale-Up
Flexible capacity across three facilities to meet demand fluctuations and growth
Our Manufacturing Process
Project Assessment
We evaluate your device requirements, regulatory needs, and production timeline to develop a comprehensive manufacturing plan
Process Development
Our engineering team designs and validates manufacturing processes, creates work instructions, and establishes quality controls
Pilot Production
Small-scale production runs verify processes, identify optimization opportunities, and ensure consistent quality output
Scale-Up & Launch
Full commercial production with real-time monitoring, lot genealogy tracking, and continuous improvement protocols
Trusted by Medical Device Leaders
“LSO's expertise in sterile packaging validation saved us months in our FDA submission timeline. Their attention to detail and regulatory knowledge is exceptional.”
“From prototype assembly to commercial production, LSO scaled with our growth seamlessly. Their Costa Rica facility gave us the cost advantage we needed for international markets.”
Explore Our Services
Specialized solutions for every stage of your medical device journey
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
Ready to Scale Your Medical Device Manufacturing?
Get a custom manufacturing plan with timeline and cost estimates for your device.
Or call us directly: (714) 672-1090