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NAMSA
Medical Device Testing

Sterilization Validation for Medical Devices

MARKET YOUR PRODUCT SOONER WITH OUR COMPREHENSIVE AND RIGOROUS VALIDATION PROCESS.

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At NAMSA, we’re known for our ability to design custom protocols that not only meet clients’ testing budgets, but are also backed by a complete documentation package that fulfills all necessary regulatory requirements for sterilization validation.

Sterilization validation for medical device studies are performed for all processes, including radiation sterilization by either gamma radiation or electron beam, ethylene oxide gas sterilization, hydrogen peroxide sterilization and thermal sterilization (both moist and dry heat).

  • Bacteriostasis/Fungistasis Testing
  • Bioburden Testing
  • Biological Indicator Sterility Testing
  • Dose Audits Testing
  • Dose Verification Experiment Testing
  • EO Cycle Development Testing
  • EO Residual Testing
  • Fractional Cycle Study Testing
  • Growth Promotion Testing
  • Half-Cycle Study Testing
  • Monitor/Notification of Quarterly Testing
  • Pharmacopoeia Sterility Testing

Resources

Literature
Biocompatibility Matrix
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White Paper
Reducing Medical Device Development Timelines & Creating Value through Biological Risk Assessments & Chemical Characterization
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White Paper
Particulates in Preclinical Testing: Understanding the Impact on Overall Device Biological Safety
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White Paper
Medical Device Biological Evaluation Reports: Relevance to ISO 10993-Part 1: 2018
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Webinar
The New ISO 10993-18:2020 – 10 Things Manufacturers Need to Know Today
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