The EnGenius Mission


The healthcare system is broken, burdened by inefficiency, high costs, and limited access to quality care. Technology offers hope as a solution 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.

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.

The EnGenius Advantage

  • Our Non-BS Manifesto

    The Non-BS manifesto is how EnGenius maximizes quality and minimizes burden. It is the cornerstone of all services offered by EnGenius Solutions and enshrines the value set that enables us to strike the optimal balance between efficiency and quality.

    The manifesto is defined by four principles:

  • Quality Over Proceduralism

    How it has been done is not how it should be done. At EnGenius, excellence is the end-goal and procedures are the means to that end. No box-ticking without a mind for quality. We don’t believe in meaningless procedural steps. Every step must assure quality - or be eliminated.

  • Culture Over Mandate

    The best system flops without culture. Not only that, culture is one of the most efficient tools to leverage in QMS implementation, defined as everyone understanding quality goals in addition to their role in achieving it and committing to achieving said goals.

    This is in sharp contrast to mandating quality. Mandates take resources to enforce but culture is self-enforcing. Mandates set the bar, cultures exceed them. At EnGenius we are dedicated to including a culture of quality in the QMS.

  • Redundancy Over Duplication

    Duplication means extra work. At best, more maintenance. At worst, misalignment. At EnGenius, we believe in system redundancy, not duplicated QMS content.

    We prefer referential over explicit inclusions: if it is captured in one place, point to it but do not duplicate it.

  • Conciseness Over Verbosity

    Words have value. They must be respected as the powerful communication packages they are. Extraneous words add extraneous communication and obfuscate the main message; at best they cause confusion and at worst, miscommunication.

    At EnGenius we believe that fluff has no place in a QMS. A Non-BS QMS is one in which the message is made clear with the least number of words necessary.

The EnGenius Founder

Ashkon Rasooli is a medical device Quality Management Systems strategist with over 12 years of experience and a focus on software as SaMD or SiMD. His unique background boasts first-hand experience in a variety of roles including product management, development, testing, QMS and regulatory and in a variety of business environments including established medical device companies with high-risk products such as Edwards LifeSciences, established tech companies with best-in-class software practices such as Alphabet's Verily, and a number of VC-backed startups at the forefront of such health tech sectors as digital therapeutics, wearables, and disease management platforms.

He is a Summa Cum Laude graduate of University of California, Irvine with a Master of Science in Biomedical Engineering and a minor in management. His master's thesis involved development of signal processing algorithms for extra-cortical recordings based on which an academic paper has been published.

With a keen interest in emerging SaMD/SiMD technologies and in particular AI, his latest activities in this area include a speakership on AI/ML applications at MD&M West 2024 and a podcast on applications of machine learning in medical devices. He is currently a member of the AFDO/RAPS Healthcare Collaborative working group on Good Machine Learning Practices (GMLP). In 2024, the working group is working on preparing a mock FDA submission for an AI-enabled device as a reference for the industry.

Track Record