Medical Device Microbiology Analysis Consulting

Lean into our microbiology analysis know-how

Medical device manufacturers require a range of microbiological services, depending on the type of product.

With experienced microbiologists on staff, our team utilizes national and international standards to derive microbiological requirements from the concept phase throughout validation, and the regulatory approval process.

Our team can serve as your liaison with a network of supporting laboratories to develop a plan to help you achieve biological safety of your medical device.

We have medical device microbiology consultants ready to work with you on custom-tailored solutions for:

  • Biocompatibility assessments
  • Biological evaluation reports
  • Cleanroom qualification and monitoring
  • Sterilization efficacy and validation studies for ethylene oxide (EO), gamma, e-beam, and moist heat (steam) processes
  • Cleaning and disinfectant efficacy and validation studies for reusable devices

Knowledge Panel

August 20, 2020

Bioburden Basics for Sterile Medical Devices

June 12, 2020

Get your Sterile Device to Market with Ease: Understanding Five Key Endotoxin Testing Requirements

Have a specific microbiology need not listed above?

Let us know. Our diverse team is available to discuss and advise.

Talk to a microbiologist!