Cleaning & Decontamination

Ensuring medical devices and surgical instruments are properly cleaned, decontaminated, and inspected is critical for patient safety, regulatory compliance, and device longevity. At Life Science Outsourcing (LSO), we provide end-to-end cleaning, decontamination, and reprocessing solutions for both single-use and reusable medical devices.

As an FDA-registered, ISO 13485-certified contract manufacturer, our controlled cleaning processes, validated decontamination methods, and rigorous quality inspections help manufacturers meet regulatory standards and ensure product integrity.

Comprehensive Medical Device Cleaning & Decontamination Services

LSO specializes in precision cleaning and reprocessing of reusable medical devices to ensure sterility, functionality, and compliance. Our capabilities include:

  • Ultrasonic and aqueous cleaning for surgical instruments and implants
  • Validated cleaning protocols to remove bioburden and contaminants
  • Regulatory-compliant processing for FDA and ISO 13485 standards

Reprocessing single-use devices can reduce waste and lower costs while ensuring compliance with FDA reprocessing guidelines. Our services include:

  • Cleaning and disinfection of single-use medical devices
  • Inspection and validation for safety and performance
  • Sterilization-ready processing to extend product lifecycle

LSO provides comprehensive processing and sterilization services for medical loaner kits, ensuring fast turnaround times and full compliance. We offer:

  • Complete kit cleaning and decontamination
  • Component-level inspection and repackaging
  • Sterile and non-sterile processing for surgical loaner kits

Returned medical devices and instruments must be thoroughly decontaminated, tested, and reprocessed before being reintroduced into the supply chain. LSO offers:

  • Advanced decontamination methods for used and returned devices
  • Validated cleaning and bioburden reduction processes
  • Full inspection and re-qualification for continued use

Every cleaned and reprocessed device undergoes rigorous quality inspection to verify sterility, functionality, and compliance. Our services include:

  • Visual, microscopic, and functional inspection
  • Residue and contamination testing
  • Compliance verification for FDA and ISO 13485 standards

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

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