The Cogmedix DFcx™ Engineering Services group is committed to supporting our customers. Our engineers become an extension of any OEM design team for any project, resulting in a high probability of time to market success.
Cogmedix provides comprehensive product development and commercialization services with extensive knowledge and expertise in the area of optical and laser-based medical devices.
Startups developing medical devices for the US market can often be unprepared for dealing with FDA regulations and preparing for an FDA product submission. Cogmedix understands the importance of quality and compliance, and proudly works with our customers to ensure they are meeting all required standards at all stages of product development and manufacturing.
As a new product comes to life from concept to commercialization, meeting our client’s objectives is critical to our success and theirs. In order to ensure we can fulfill each client’s objectives in the dynamic product development environment, we have found that following a structured phase gate development process provides the necessary foundation and roadmap to bring a product to market at WARP SPEED.
Medical device product development and commercialization can be challenging, especially when technology innovation is critical to developing your product. Cogmedix’s Design Control process has four distinct phases of development to maintain compliance while fast-tracking technology innovation.
Longtime Coghlin Companies employee, Craig Thompson, reflects on his transition from a machine shop welder to an experienced engineering technician.
By Chad Graham, Electrical Engineering Manager As with life, the medical industry is a constant balance of risk versus benefit. In the medical device sector, a medical device’s class is used as a means of classifying how risky a device is and, by extension, what...
Cogmedix recently had the pleasure of attending BIOMEDevice Boston, sponsored by MD&M. It was a great opportunity to engage with many Cogmedix suppliers, customers and design partners, as well as meet new companies showcasing their varying capabilities.
When selecting the materials that will make up a medical device, one of the most important steps is considering the FDA requirements for flammability, biocompatibility and environment compatibility. These requirements are necessary for a marketable device, but not for a functional prototype. It is common during technology development to focus on core functionality and delay meeting some regulatory requirements until the product design stage. Once the product design commences, it is possible to experience difficulty finding materials that meet both core functional and regulatory requirements.