Perfect FDA Inspection

Cogmedix, a US-based, FDA compliant medical device manufacturer, announced the completion of a successful FDA inspection. Cogmedix passed the routine inspection, receiving no FDA Form 483s – the official FDA inspectional observation sheet which lists any and all significant objectionable findings noted during an inspection. As a result, Cogmedix’s file with the FDA will list the company status as NAI, or, no action indicated.

As part of the comprehensive three-day inspection, an FDA investigator observed assembly, receiving inspection, and in-process inspection resources and processes, and examined several components of the company’s Quality System including:

• Organizational charts
• The Quality Manual 
• Internal auditing
• Manufacturing agreements 
• Random device history records 
• Product non-conformances 
• Device master records
• Training records
• Calibration records

“The Cogmedix Quality Management System is the foundation of our business, and our team works diligently to consistently meet the highest standards,” said Matt Giza, General Manager, Cogmedix. “This successful inspection not only affirms our commitment to quality and compliance, but validates our exceptional execution of these values as well.”

About Cogmedix
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 specializing in helping companies cost effectively improve their time-to-market. Based in Worcester, Massachusetts, Coghlin Companies spans four generations representing more than 126 years of manufacturing experience and leadership. Subsidiaries include: Columbia Tech, which provides turnkey manufacturing services to a diverse customer base, including OEMs in the bio-science, semiconductor, LED, medical device, green energy technology, data storage, and automation systems and controls industries; DCI Engineering, an engineering design and pre-production support services company; and Cogmedix, an FDA compliant and ISO 13485 certified medical subassembly and finished medical device contract manufacturer. For more information, please visit www.coghlincompanies.com or sign up for the Coghlin Companies e-Newsletter at http://coghlincompanies.com/newsletter-signup.php.