Industries & Markets We Serve
FDA-registered contract manufacturing for orthopedic, cardiovascular, dental, diagnostics, neuromodulation, and specialty medical devices. Assembly, packaging, sterilization under one ISO 13485 quality system.
Life Science Outsourcing serves medical device manufacturers across the full spectrum of regulated industries — from Class II implantables to IVD consumables. Our FDA-registered facilities, ISO 13485 quality system, and 25+ years of experience mean we understand the specific manufacturing, packaging, and sterilization requirements that each market demands.
Primary Industries We Serve
LSO serves medical device companies across four core markets with specialized manufacturing expertise and regulatory compliance:
Orthopedic Devices
Implants, surgical instruments, trauma fixation, spinal systems, and loaner kit reprocessing with ISO 13485 quality systems and specialized cleanroom capabilities.
Dental Solutions
Dental implants, instruments, and prosthetic components manufactured in controlled environments with precise assembly and sterilization validation.
Diagnostics & IVD
Microfluidic cartridges, reagent packaging, lateral flow devices, and point-of-care consumables with precision assembly and reagent formulation expertise.
Cardiovascular Devices
Catheters, leads, delivery systems, and cardiac rhythm management devices with Class 5-8 cleanroom assembly and comprehensive sterilization services.
Beyond our primary industries, LSO provides contract manufacturing services for a wide range of regulated medical device categories:
Additional Markets We Serve
Neuromodulation
Pain management devices, deep brain stimulation systems, and micro coil delivery systems for aneurysm embolization.
Electrophysiology & Cardiac Rhythm Management
Diagnostic and ablation catheters, lead delivery systems, implantable pulse generators, and cardiac resynchronization therapy devices.
Trauma & Extremities
Fixation plates and screws, alignment devices, surgical guides, and wound care products.
Minimally Invasive Devices
Less invasive surgical instruments, structural heart disease devices, and drug delivery systems.
Respiratory & Neonatal
Premature birth respiratory distress accessory systems and related neonatal devices.
Gastrointestinal & OBGYN
Catheter systems for GERD treatment, uterine devices, sampling devices, and complex harvesting systems.
Drug Delivery & Fluid Management
IV sets, IV drug delivery devices, infusion systems, and drainage systems.
Specialty Kits
Sterile suction cannula kits, adipose tissue harvesting kits, and custom surgical kits.
End-to-End Capabilities for Every Market
Regardless of your device category, LSO provides the same comprehensive suite of regulated services:
Cleanroom Assembly & Kitting — Class 5–8 environments matched to your device classification
Packaging Validation — ISO 11607 from protocol design through production
Sterilization & Validation — EtO, gamma, e-beam, steam, and VHP under one roof
Cleaning & Decontamination — Validated reprocessing for reusable devices and loaner kits
Diagnostics Manufacturing — Precision reagent packaging and cartridge assembly
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