Continuing to meet the complex needs of medical device companies, Cogmedix, a US-based, ISO13485-certified, FDA compliant contract manufacturing and services company, will provide Massachusetts-based Telcare Medical Supply with FDA compliant storage and global order fulfillment services for their Class II medical device, Telcare BGM.
Telcare’s FDA and HIPAA-compliant solution, Telcare BGM, is the world’s first cellular-enabled glucose meter. Paired with Telcare’s back-end clinical server and a suite of smartphone applications, the Telc are BGM™ blood glucose meter provides a complete ecosys tem of care. Telcare’s FDA-cleared HIPAA- compliant server connects directly to electronic medical record systems and is accessible via a secure, online portal where users and their caregivers can monitor current and historical readings, set up messaging options delivered directly to the meter, adjust personalized blood glucose target zones, and print reports.
“Telcare will leverage the Cogmedix team’s flexibility and compliance expertise, while taking advantage of the company’s controlled inventory management with environmental monitoring,” said David Bjork, President of Telcare Medical Systems. “Working with Cogmedix offers us the flexibility to deploy our own inventory management software at their facility, while enabling the Cogmedix team to be a seamless extension of our business management processes.”
“While Cogmedix can expertly manage the entire medical device manufacturing and fulfillment process, we are also happy to partner with companies like Telcare that require a subset of our expertise for various stages of their outsourcing strategy,” said Matt Giza, General Manager, Cogmedix. “Our work with Telcare demonstrates our order fulfillment capabilities, including the ability to store in appropriately segregated, monitored and controlled facilities, combined with receiving orders, and picking, packing, and shipping serialized and lot controlled inventory. Our service will help enable Telcare to focus on continued product innovation and their customer call center, while optimizing their overhead cost structure.”
Cogmedix is a US-based, FDA QSR compliant, ISO 1348 5 certified 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 Cogmedix.