Essenvia is an online software to streamline pre and post market workflow for medical device companies by streamlining plans or activities to market, improving cross-functional collaboration and automating steps to manage initial and subsequent device modifications. It takes 2-5 years for new or improved medical devices to reach market and medical device companies manage a complex, specialized workflow prone with errors. Research shows regulatory submissions have grown in complexity and size, with a consistent 30% rejected at initial review and 64% sent back for additional information costing the industry billions of dollars each year. Our program is designed to help drastically reduce submission errors, streamline data and information gathering, save time, and help you submit a close to rejection proof as possible 510k submission.