Dental Laser Medical Device Manufacturing
The team at Cogmedix has established expertise in the contract manufacturing of dental laser devices, building some of the most innovative products in this industry. Our experience makes us a leading medical device contract manufacturer and guarantees compliant, high-quality work for our clients.
Highly Trained Team of Experts
Manufacturing laser-based medical devices is a core competency at Cogmedix. We are able to assist and improve every step of the manufacturing process, including product engineering, design for manufacturability and assembly, identifying suppliers and sourcing materials, optical and custom laser chamber assembly, alignment and calibration, test protocols, final product assembly, and quality control. Cogmedix is also able to manage the shipment of the finished product to your facility, your freight forwarder, or directly to the end user on your behalf.
Professional, competency based training is—and will remain—the primary focus at Cogmedix. We continually train our Caring Associates on best practices and have continuous operational improvement plans in place. Fully trained associates and exceptional client engagement are critical elements of the Cogmedix model.
FDA-Compliant Manufacturing and Assembly Services for Hard and Soft Tissue Dental Lasers
Because laser-based dental devices are governed by the Food and Drug Administration (FDA) and other international agencies, we regularly support and host audits by our customers, their registrars, nationally recognized test labs (NRTLs), and other international regulatory bodies. Cogmedix has been successfully inspected by the FDA, the Massachusetts Radiation Control Program, as well as agencies from other countries, including but not limited to, ANVISA and the Korean Ministry of Food and Drug Safety.
Our state-of-the-art manufacturing facility includes six dedicated laser-safe test labs overseen by a certified laser safety officer (LSO). We are well versed in the sourcing, handling, integrating, and testing all laser classifications; from Class I through Class IV. We are also registered with the Massachusetts Department of Public Health, Radiation Control Program and are subject to audits by them. Our facilities, equipment and trained staff are made available to our clients to ensure the best results. With Cogmedix, there is no need to invest in your own manufacturing facility or ramp up staff; we have everything you need for efficient and unwavering dental device manufacturing.
Convenient and Cost-Effective Medical Device Manufacturing
Cogmedix is based in Worcester, Massachusetts, just an hour’s drive or train ride west of Boston. We are located in an area with many technological resources and multiple transportation options. Our location makes it easy for your team to collaborate with ours to ensure great relationships, quality and compliance.
For more information about how Cogmedix helps bring laser-based dental devices to market, contact us today.