Microbiological Testing for Sterile Medical Devices


  • What is microbiological testing for medical devices?
  • Which device types require microbiology and sterility testing?
  • How do we determine the testing requirements for our device?

The ISO 13485 quality system standard, and regulators in the US and Europe, require medical device manufacturers to eliminate or reduce contamination risks in their production processes that could cause infections in patients or users. For devices labeled sterile, microbiological and sterility testing are required in most major markets and you must document the results of those tests in your regulatory submission.

Emergo can help you identify the testing requirements for your sterile device and perform the necessary testing.

Microbiological testing requirements for sterile medical devices

Sterile device manufacturers must ensure adequate and microbiologically secure manufacturing conditions, even if they outsource some or all of their manufacturing to third parties. Final sterilized products, as well as packaging materials, must often undergo additional evaluations to support sterilization claims.

Failure to complete the appropriate testing can delay the regulatory process for your device. Emergo can help you determine the microbiology testing you need based on your device type and testing requirements in your target market.

Microbiology testing and documentation in support of regulatory submissions

In collaboration with our colleagues at UL, we can perform the required microbiology and sterility testing for your device. Our testing experts utilize the latest methods and equipment to assess and validate your device sterilization claims. Our microbiology tests can determine the sterilization status of your medical device, assess anti-infective properties of your device materials, and identify ways to control your manufacturing and sterilization processes.

Our microbiology and sterility testing services include:

  • Bioburden determinations
  • Sterility testing and validation
  • Differentiation and detection of pathogenic microorganisms
  • Endotoxin testing (LAL tests) for invasive devices
  • Antimicrobial activity testing
  • Microbiological monitoring of production

We provide a detailed report summarizing the results of the testing. Our regulatory consultants are experts in testing requirements in various markets and can help you prepare the necessary documentation for your FDA 510(k), European Technical File, and other submission types in markets worldwide.

Count on our decades of expertise in testing to help you determine the exact regulatory requirements for your device.

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