"Edge Innovative Solutions filled a critical role for our organization’s R&D team as we were tasked to transfer our European-developed (German) engineering models and documentation into a suitable format that could be submitted to the FDA for pre-market approval in the US. This involved recreating over 500 legacy CAD models, assemblies and drawings that were originally created in several different MCAD packages (ACAD, Pro Engineer, and SolidWorks) into one consistent and organized SolidWorks database managed within our DB Works Enterprise PDM system (DBWorks). Having a wealth of experience in medical device development and other regulated industries, EIS worked within our Design Control and Quality System processes to ensure that our product data remained accurate and had a smooth transformation into our new FDA caliber Device Master Record."
"Although much of the project work could be done offsite, with EIS’s command of SolidWorks and Enterprise PDM systems and knowledge of the latest tools in remote networking, the working relationship seemed as if they were a seamless extension of our internal development team. We will continue to use Edge for projects in the future."
Keith Bradley
R&D Manager
SANUWAVE, INC.