We believe in a unique and customized consulting experience for each and every client without exorbitant consulting rates. We strive for a strong working relationship to ensure your objectives are understood -- together we can achieve a high level of medical device performance, safety, manufacturability, and quality.
As a mid-sized contract manufacturer, the key to our on-time delivery is cultivating supplier partnerships, maintaining a quality management system compliant to worldwide regulations, and fostering a GMP mindset within our associates.
As a contract developer, we focus on establishing the right size team that has the experience and bandwidth to create a comprehensive Design History File, Technical File, and Device Master Record for your medical device.
Our skills as both developers and manufacturers enable us to efficiently resolve design changes which are a common part of the medical device development lifecycle. We can quickly and efficiently update the necessary regulatory documentation, and then manufacture new devices for verification, validation, clinical investigation or commercial release.