Medical Device Advice, Inc.

1 888 290 6677 or +1 647 200 3353

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    • HOME
    • ABOUT US
    • USA
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      • FDA-NEWS
      • HEALTH CANADA-NEWS
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1 888 290 6677 or +1 647 200 3353

Medical Device Advice, Inc.

  • HOME
  • ABOUT US
  • USA
  • CANADA
  • EU & ROW
  • STERLIZATION
  • NEWS
  • CONTACT US

STERILIZATION

We have over 25 years of sterilization experience specializing in Ethylene Oxide (EtO), Radiation  (Gamma and E-Beam) and Steam sterilization processes.   


Our services include: 


●   Writing validation protocols in accordance with ISO/AAMI standards            


▪Ethylene Oxide - ISO 11135 series           

▪Steam- ISO 17665           

▪Radiation- ISO 11137 series 


●  Managing the execution/implementation of the protocols 


●  Reviewing data and writing final report(s) 


●  Co-ordinating microbiological testing with the appropriate laboratories
     

▪Bioburden testing and method validation      

▪Sterility testing, Bacteriostasis and Fungistasis testing     

▪Ethylene Oxide residual testing 


●  Providing assistance with troubleshooting any sterilization failures  


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