Medical Devices

Medical Device Testing Services

Focused on all aspects of product quality and safety, we can assist with validation in the following areas:


  • Antimicrobial efficacy
  • Cleaning/disinfection validation targeting microbes
  • Microbial isolate identification


  • Raw material testing and verification


  • Viral clearance for animal tissue or human blood-derived medical devices
  • Viral inactivation/disinfection validation for blood glucose monitoring systems (BGMS), targeting Hepatitis B virus (HBV) and HIV
  • Influenza virus claim for treated face masks and textiles per AATCC 100
  • Condom Viral Barrier Testing per ISO 23409, ISO 25841
  • Virucidal efficacy for surgical gloves

In-vitro Toxicology

  • Agar Overlay Cytotoxicity Assay per ISO 10993-5
  • Direct Cell Contact Cytotoxicity Assay per ISO 10993-5
  • MEM Elution Cytotoxicity Assay per ISO 10993-5
  • MTT Cytotoxicity Assay per ISO 10993-5
  • Neutral Red Uptake Cytotoxicity


  • Materials compatibility
  • Package strength & integrity
  • Failure analysis (product and packaging)