Our team has extensive experience in bringing Class II and Class III medical devices from initial prototypes through to commercial product launch. We have worked on products that are being used in hospitals and in homes today.

We work with your marketing, engineering, and manufacturing teams to bring your product to market on time and on budget. Whether you are commercializing a new technology or cost-reducing an existing product, we can speed your development time and decrease your risk.

Our design, validation and verification methods comply with FDA and IEC regulations. We can work within your existing software development process, or help you to define a process that meets design control requirements while still achieving time-to-market objectives.