Rapid Regulatory Strategy for Teams Building the Future of Healthcare
Unigen helps early-stage and scaling med-tech teams move efficiently from concept to regulatory submission. Whether you're building AI-enabled diagnostics, clinical decision support (CDS) tools, machine learning–powered medical imaging systems, cloud-connected digital health platforms, or remote patient monitoring tools, we translate complex regulatory expectations into fast, actionable deliverables that support your pace of innovation.
Digital health teams today are building technologies that move faster than the regulatory frameworks around them: AI models that support diagnosis, machine learning tools that analyze medical images, predictive algorithms that identify high-risk patients, and software that adapts continuously based on real-world data. Yet many early-stage teams stall, not because their technology is weak, but because the regulatory process is opaque, expensive, and mismatched to how modern software is built.
Startups often face two extremes: enterprise QMS platforms they’re not ready for, or traditional consultants who apply outdated processes built for legacy hardware rather than ML-enabled SaMD or next-generation diagnostics.
Unigen was founded in 2025 to bridge that gap. We offer a clearer, more flexible approach to regulatory strategy, one designed for innovators building AI/ML medical devices, digital therapeutics, advanced imaging analytics, and data-driven clinical workflows. Our mission is simple: help teams understand exactly what regulators expect, move confidently through each development stage, and use regulatory strategy as a catalyst for innovation rather than a barrier.
Our Story
How We Accelerate Your Path to Market
1. We Diagnose Your Regulatory Needs Quickly
We rapidly map your product to the correct regulatory pathway, whether it’s SaMD, AI-enabled software, advanced imaging analysis tools, or a traditional medical device. We define classification, identify applicable standards, clarify evidence expectations, and determine the best submission route for FDA, Health Canada, EU MDR/IVDR, and UKCA markets. You get clarity from day one and avoid weeks of uncertainty or rework.
2. We Build a Fast, Actionable Compliance Plan
Using the right blend of medical device and software standards, we create a focused plan that links user needs, requirements, risks, and verification steps. This approach works especially well for AI decision-support engines, predictive analytics models, and cloud-native digital health software, where traditional documentation often breaks down.
3. We Streamline Documentation With Modern Tools
We use AI-assisted drafting, structured templates, and version-controlled workflows to produce clean, regulator-ready documentation quickly. Whether you’re building computer-vision radiology tools, algorithmic triage systems, or EHR-integrated clinical software, we ensure your documents reflect how modern development teams actually work, without forcing you into expensive new systems.
4. We Keep Engineering, Clinical, and Product Teams in Sync
Regular touchpoints and transparent documentation pathways ensure every stakeholder understands what’s needed and why. This eliminates miscommunication, circular conversations, and last-minute delays.
5. We Guide You Smoothly Through Submission
Once documentation is ready, we support FDA, Health Canada, EU MDR/IVDR, and UKCA submissions, manage regulator questions, and help you navigate review cycles with confidence. Whether you're filing a 510(k) for AI-assisted diagnostic software or preparing technical documentation for an ML-enabled imaging analysis tool, we make the path predictable and efficient.
Who We Work With
We partner with innovators across the med-tech landscape, including:
Early-stage founders building their first AI-enabled SaMD or device
Clinician-innovators developing in-house clinical decision support tools who are considering going to market
Growing digital health teams preparing for FDA, Health Canada, EU MDR/IVDR, or UKCA submissions
Companies scaling digital therapeutics, remote patient monitoring solutions, or predictive analytics tools
Established streamlining documentation for their next submission
II you’re building technology that pushes healthcare forward, we’re built to support you.