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.

EnGenius Services

Early Regulatory and Quality Strategy

  • Regulatory Pathway Analysis

  • Pre-Submission Strategy

  • Quality System Readiness

  • Fundraising & Investor Support

  • Gap Assessments & Risk Planning

QMS Support

  • QMS Development & Implementation

  • eQMS Selection & Administration

  • Internal Audits & Regulatory Compliance

  • Process Optimization & Efficiency

  • Training & Staff Development

  • Fractional Quality Lead or Staff Augmentation

AIMD/MLMD/SaMD Specialty

  • AI Enabled Tools or Products

  • AI/ML Regulatory Strategy

  • SaMD Lifecycle & Documentation

  • Algorithm Validation & Bias Mitigation

  • Cybersecurity & Risk Management

  • Real-World Performance Validation

Early Regulatory and Quality Strategy

Navigating regulatory requirements early in development is critical to avoiding costly delays. EnGenius helps companies build a solid regulatory and quality strategy from the outset, aligning with FDA, ISO 13485, and other global standards. Whether you're preparing for fundraising, product commercialization, or investor scrutiny, our strategic guidance ensures your pathway to compliance is efficient, well-structured, and tailored to your product's needs.

Client Testimonial

"For a client of ours, EnGenius provided a comprehensive cybersecurity compliance proposal that was instrumental in both our fundraising efforts and the commercialization of our new product.

Their detailed budgeting and implementation estimates gave us a clear roadmap for achieving compliance, strengthening our discussions with investors and ensuring a smooth path to market. Their expertise and thorough approach made a complex process much more manageable."

Christian Busch
CEO, Mulligan Valley Partners

General QMS Support

A well-designed Quality Management System (QMS) should enhance, not hinder, your business operations. EnGenius provides expert support in developing, optimizing, and maintaining QMS frameworks that meet ISO 13485, 21 CFR 820, and other regulatory requirements while minimizing administrative burden. From implementation and process improvement to training and internal audits, we ensure your QMS is both compliant and practical for your organization.

Client Testimonial

“As a contract manufacturer for medical device companies, ISO 13485 compliance is critical for our business. Ashkon has been instrumental in setting up our QMS, ensuring that our processes align with compliance requirements while seamlessly integrating with our existing operations. His ability to balance regulatory intent with minimal overhead has been invaluable. Additionally, his partnership with our eQMS provider made the entire implementation process significantly smoother.

Beyond implementation, EnGenius has also provided invaluable training and support to our internal team, ensuring we have the knowledge and confidence to maintain compliance independently. Their hands-on approach has set us up for long-term success.”

Vivian Allen
CEO, SigmaPro Engineering

SaMD/AIMD/MLMD Speciality

Software-driven and AI-enabled medical devices present unique regulatory challenges, requiring specialized expertise. EnGenius has deep experience in the regulatory landscape for Active Implantable Medical Devices (AIMD), Machine Learning Medical Devices (MLMD), and Software as a Medical Device (SaMD). We help companies navigate evolving FDA and global AI/ML regulations, develop validation strategies, and ensure compliance while maintaining innovation speed.

Client Testimonial

"EnGenius Solutions’ expertise in AI and software has been a game-changer for us. Their team provided invaluable guidance in developing validation strategies for our AI-enabled compliance tool, ensuring regulatory alignment. 

We continue to rely on their expertise through an ongoing, as-needed engagement whenever we need support in medical software, AI, or SaMD compliance."

Justin Dierking, 
Co-Founder, myQMS.ai