Medical device contract manufacturer reinforces commitment to safety and compliance with specialized facility
Online PR News – 21-December-2010 – – Cogmedix, a US-based, FDA compliant contract manufacturer for medical devices, formally announces its registered Class 4 laser facility, compliant with the requirements of American National Standards Institute Z136 Guidelines and 105 CMR 121.000.
Lasers are increasingly integrated into a wide range of medical products, including various diagnostic and imaging systems, skin treatment processes, ophthalmic assessment and surgical procedures, and other surgical lasers such as those used for removal of kidney stones. Cogmedix has met this growing industry demand by establishing a laser facility compliant with relevant government safety regulations, thus mitigating the risk of laser light exposure in the manufacturing process. In accordance with this registration, the company has an appointed Laser Safety Officer (LSO) responsible for monitoring and overseeing the controls of laser hazards.
“Safety and compliance make up the core of our culture at Cogmedix,” said Matt Giza, General Manager of Cogmedix. “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 the Cogmedix facility complies with all applicable safety standards, we worked with independent third party radiation safety consultant International Radiation Safety Consulting, Inc (IRSC). IRSC performed a laser safety audit and gap analysis and helped us formalize a Laser Safety Program Manual to guide our day-to-day laser-based medical product manufacturing.”
“We are continuously impressed with Cogmedix’s commitment to compliance, quality, and safety, and the company’s newly registered facility is yet another example of this dedication,” said Jose do Val of Eleme Medical, a Cogmedix customer. “Our SmoothShapes® body shaping product revolves entirely around non-invasive laser technology to treat cellulite and subcutaneous fat, and it gives us great confidence that Cogmedix has laser compliance and safety at the forefront of its operations.”
Cogmedix is a US-based, FDA compliant contract manufacturer for medical and clinical devices. A subsidiary of Coghlin Companies Inc., Cogmedix focuses on the production of Class I and Class II medical and clinical devices for the critical care, home healthcare, emergency room, and industrial laboratories markets. Cogmedix focuses on aligning itself with companies seeking a compliant, conscientious, cost effective, domestic manufacturing resource to assist them with volume turnkey manufacturing. For more information about Cogmedix, please visit www.cogmedix.net.
About Coghlin Companies, Inc.
Coghlin Companies, Inc. is a privately held company in Worcester, Massachusetts spanning four generations for over 125 years. Subsidiaries include: Columbia Tech, which provides turnkey manufacturing services to a diverse customer base, including OEM’s in the telecommunication, semiconductor, machine tool, medical device, alternative energy, data storage, and networking industries; DCI Engineering, an engineering services company; Coghlin Precision, a precision machining and certified welding company; and Cogmedix, an FDA compliant medical and clinical device contract manufacturer. For more information, please visit www.coghlincompanies.com.