Cogmedix (Worcester, MA) has registered a Class 4 laser facility compliant with the requirements of American National Standards Institute Z136 Guidelines and 105 CMR 121.000. The contract manufacturer is opening the dedicated facility for integrating lasers into a variety of medical products, including diagnostic and imaging systems, skin-treatment processes, ophthalmic assessment and surgical procedures, and surgical equipment such as that used to remove kidney stones.
The company has met the growing industry demand for lasers by establishing a compliant facility to mitigate the risk of laser-light exposure in the manufacturing process. In accordance with this registration, the company has appointed a laser safety officer responsible for monitoring and overseeing the control of laser hazards.
"Safety and compliance make up the core of our culture at Cogmedix," remarks Matt Giza, Cogmedix's general manager. "In order to do business with customers developing leading-edge laser technology, it is essential to provide a facility that is equipped to handle the technology safely." To ensure that the new facility complies with all applicable safety standards, the company worked with International Radiation Safety Consulting Inc. (Holbrook, MA; IRSC). IRSC performed a laser safety audit and gap analysis, helping Cogmedix to formalize a laser safety program manual to guide its day-to-day laser-based medical product manufacturing.