EnGenius Solutions LLC

The healthcare system is broken, burdened by inefficiency, high costs, and limited access to quality care. Technology offers hope by bridging these gaps through telemedicine, big data, AI and much more. The importance of technological adoption is a moral obligation for equitable access to care and a reimagined, inclusive healthcare model. Yet embracing these solutions - the development of which often requires agile and iterative development models - has always been slower than desired due in part to a lack of optimized, scalable, tailored medical device development processes within the Quality Management System. As a medical device QMS firm focused on SaMD and SiMD, our mission is to streamline safe and sustainable integration of technology into the healthcare sector. With a focus on innovation and efficiency in addition to safety, quality and compliance we tailor solutions designed to simplify adoption of technology into the health care ecosystem generally and the medical device space specifically in order to enable bridging of the gap between the current healthcare practices and modern technological advancements. This mission demands Engineering and Genius, and EnGenius is up to the task.