​Services for Medical Device Manufacturers

Let us share our experience with you

As active participants in the medical device standards making process and active involvement with sterile processing departments, we get unvarnished user feedback about reusable medical devices, their reprocessing, their IFUs, and all the things that are good and bad about device design.

And we can share it with you, the medical device manufacturer.

Difficulty with any design or documentation feature will lead to feedback up the chain to the doctor, and no informed doctor wants to use a device that can’t be rendered safe for use on the next patient.

Our experience in assisting manufacturers of reusable devices and reprocessing equipment can be brought to bear on your design process, so you don’t have to go down the path others have followed to places they never wanted to go…

If it is a complex device, a sterilizer, a washer, a disinfector, a cleaning or disinfection chemistry, we have been involved with it.

Areas of Expertise:

  • Rigid Endoscopic Devices
  • Flexible Endoscopic Devices
  • Orthopedic Instruments and Power Tools
  • Sterilizers
    • Steam -  Ethylene Oxide  -  Hydrogen Peroxide/Plasma
  • Washers and Washer/Disinfector
    • Thermal and Chemical Disinfection
    • Alkaline and Enzyme Detergents
  • Design for Sterilizability
  • Design for Cleanability
  • Human Factors, including design for reprocessing
  • IFUs utilizing standard cycles and methods and clear writing style