Sterile Product

Reducing the risk of hospital acquired infections (HAI’s) is essential to patient safety in today’s health care environment.  At CFI, we adhere to high standards and maintain rigorous controls to ensure product integrity from manufacture through to the time of procedural use.  Here are some of the key standards that we adhere to:

• FDA 21 CFR Section 820 Quality System Regulation
• ISO 13485 Medical Devices Quality System Requirements
• ISO 14644 Clean room and associated controlled environments
• ISO 11607 – Packaging for Terminally Sterilized Medical Devices Parts 1 & 2
• ISO 11135 – Sterilization of Healthcare Products – Ethylene Oxide
• ISO 10993-7 – Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Whether your need is an individual product or a series of components packaged as a kit, CFI can work with you to achieve the balance of cost and compliance.

Contact CFI for assistance with your next sterile product manufacturing need.