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. 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.
I am a seasoned technologist, product leader in Healthcare with over 16 years leading strategic transformation initiatives at Fortune 500 companies. It is during this time that I experienced first hand how complex, manual and painful regulatory processes are. I founded Essenvia to solve this problem.