Medical Device Manufacturing for Bay Area Startups & OEMs
Streamline your Bay Area medical device launch with LSO—packaging, sterilization, and compliance, all under one roof
From concept to commercialization, LSO simplifies your supply chain with all-inclusive in-house services—serving San Francisco and the wider Bay Area from our Southern California hub.
Strategically Located to Serve Bay Area MedTech
You don’t need a vendor next door—you need a partner who understands the regulatory landscape, moves at startup speed, and eliminates bottlenecks. LSO supports Bay Area innovators from our Southern California facility with:
- Overnight transit from SoCal to San Francisco
- Pacific Time zone alignment for real-time collaboration
- Dedicated project managers who know your market
We proudly serve MedTech companies across:
• San Francisco • San Jose • Palo Alto • South San Francisco • Fremont • Mountain View • Oakland
Ditch the Vendor Juggling Act
Many OEMs and startups work with multiple vendors for packaging, sterilization, testing, and logistics. That means multiple contracts, timelines, handoffs—and higher risk.
LSO brings everything under one roof, so you can:
- Work with a single, accountable partner
- Save time and reduce freight costs
- Eliminate vendor-to-vendor delays
- Stay audit-ready with harmonized documentation
One contract. One process. One launch-ready solution.
Our In-House Services—End-to-End Execution
We support every stage of your device’s commercialization journey. Whether you're preparing for clinical trials, submitting for FDA clearance, or scaling into production, LSO delivers:
Medical Device Assembly
- Manual and semi-automated assembly
- Cleanroom Class 10,000 (ISO 7) and 100,000 (ISO 8)
- Device subassembly and integration
Sterile & Non-Sterile Packaging
- Pouching, tray sealing, vacuum sealing
- Labeling, barcoding, IFU insertion
- Packaging design support for ISO 11607 compliance
Sterilization (EO, Gamma, Steam)
- Ethylene Oxide (EO), Gamma Irradiation, Steam
- Sterility validation and routine processing
- Real-time monitoring and lot release testing
Package Testing & Validation
- Transit simulation (ISTA/ASTM)
- Accelerated aging, dye penetration, burst & bubble leak
- ISO 17025 accredited laboratory
Regulatory & Quality Support
- FDA submission guidance
- Validation protocols & reports
- Device Master Records & DHF compliance
Logistics & Warehousing
- 3PL support for clinical and commercial fulfillment
- Temperature-controlled storage
- Kitting and final-mile coordination
Built for Speed.Backed by Compliance.
With over 25 years of industry experience, LSO combines operational excellence with deep regulatory expertise. We're built for innovators and validated by enterprise-grade quality systems.
- FDA Registered
- ISO 13485 Certified
- ISO 17025 Testing Lab
- Cleanroom Environments
- Submission-Ready Documentation
“We’ve passed every audit, and helped dozens of Bay Area medtech startups go from concept to shelf.”
Trusted by Northern California MedTech Innovators
From orthopedics to diagnostics to combination products, we’ve supported launches across the Bay Area’s leading device categories. Our clients include startups, growth-stage firms, and publicly traded OEMs—all looking for a reliable, simplified path to market.
“Working with LSO was like adding an internal operations team. Everything just flowed—and we launched weeks ahead of schedule.” — Director of Operations, MedTech Startup, Palo Alto, CA
FAQs from Bay Area Companies
Shipping & Transit – West Coast Aligned
We’re based in Southern California, but we move fast for the Bay Area.
- 1–2 Day Ground Shipping
- Courier Support Available
- Same Time Zone = Real-Time Communication
- Service Area: San Francisco, San Jose, Oakland, Palo Alto, Fremont, and beyond
Simplify Your Path to Market—Partner with LSO
When it comes to getting your medical device to market, complexity kills timelines. LSO simplifies the entire supply chain—so you can focus on innovation, not coordination.
- Fewer vendors
- Faster validation
- Seamless documentation
- Proven compliance
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