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Infection Control Device Expertise

MDCI works with infection control device manufacturers to meet compliance and regulatory requirements to bring the following products to market:

• Systems for cleaning and disinfection/sterilization of reusable medical devices
• Liquid chemical germicides
• Chemical and biological indicators

Infection Control Device Case study

A European manufacturer of a tabletop steam sterilizer sought to commercialize its product in the U.S, but had difficulty understanding the FDA requirements for the demonstration of sterilization efficacy, for a number of reasons. First, the European requirements for demonstrating disinfection and sterilization are very different from those of the FDA. And, while the FDA did have a guidance document published that pertained to this type of device, it was outdated. In addition, the FDA had a number of additional unpublished requirements based on international performance standards developed for this product. Finally, the company was aware that its existing electronic control system did not meet FDA software documentation requirements. MDCI was able develop the appropriate testing program for the tabletop steam sterilizer device, and ultimately worked with the client to develop and prepare the necessary software documents, some from scratch, in order to successfully meet the FDA requirements.

Contact us today to learn more about our infection control device expertise.