Accelerating Regulatory Success for Digital Health and MedTech Innovators
We guide early-stage MedTech teams through the regulatory steps required to become fully compliant medical device manufacturers efficiently and without unnecessary overhead.
Medical technology and digital health startups are typically unprepared for the regulatory requirements, costs, and time needed to bring their products to market. Whether you're developing software as a medical device (SaMD) or connected devices leveraging cutting edge AI functionality, Unigen gives your organization the tools to establish a compliant software development environment, deploy an audit-ready quality management system, and map out a post market strategy to ensure ongoing patient safety, model accuracy, and user satisfaction.
Services
Rapid Regulatory Pathway & Risk Assessment
Clarity in days, not months
Get clarity fast on what you’re building, how it will be classified, and what is required for FDA, Health Canada, EU MDR/IVDR, and UKCA pathways. We take your concept, prototype, or pitch deck and map it to the correct regulatory pathway, identify applicable standards, flag AI-related risks early, and outline realistic timelines and next steps. This gives founders immediate direction before investing months into development or expensive compliance tools.
Lightweight Compliance Planning
Only the processes you need, none that you don’t
Instead of pushing you into a full QMS too early, we help you build a simple, scalable compliance plan that fits your stage. This includes just the essential processes, risks, and documentation you need to stay aligned with ISO and regulatory expectations, without slowing product velocity. It’s a smart, cost-effective foundation that prevents rework later and keeps you on a clear path toward a more formal QMS when the time is right.
Documentation & Standards Support
Submission-ready documentation without the complexity of a full QMS
We help you create clean, audit-ready documentation that keeps regulators confident without overwhelming your team. Whether you need risk management files, software lifecycle documents, traceability matrices, clinical claims alignment, or AI/ML-specific evidence support, we deliver only what’s necessary. You get high-quality documentation that strengthens your submission without the usual complexity or overhead.
Learn how our services can cut regulatory uncertainty, reduce costs, and accelerate your path to market.
Resources
Medical Device Regulation 101: How to Prepare for (and Survive) FDA Approval
If you are building your first medical device or SaMD product, the FDA approval process can feel confusing, expensive, and full of hidden hurdles. This guide breaks down the essentials you need to understand from day one, including how your intended use shapes risk classification, which regulatory pathway your product will follow, why innovation often slows approval instead of speeding it up, and what quality and documentation steps you should put in place early. Start here to get a clear, founder-friendly roadmap through the regulatory landscape and learn how to navigate it with confidence.
How Intended Use Shapes Your SaMD Classification and FDA Pathway
Before you can choose a regulatory pathway or even draft your first requirements document, you need to define your SaMD’s intended use. This single statement determines your risk classification, evidence expectations, and whether your product qualifies for a fast 510(k), a longer De Novo, or a full PMA. In this guide, you’ll learn how intended use shapes your entire regulatory strategy and how to position your software (especially AI-enabled tools) for the right pathway from the start.
Choosing the Right Predicate Device: The Most Important Step in Your 510(k) Strategy
Before you can prepare a 510(k), you need to choose the predicate device your product will be compared against, and this single decision can determine whether your submission moves quickly or gets pushed into a longer De Novo or PMA pathway. For SaMD and AI-enabled tools, predicate selection shapes your intended use, evidence needs, testing strategy, and how FDA interprets your technology. In this guide, you’ll learn how to evaluate potential predicates, avoid common traps, and choose the device that positions you for the fastest and most successful clearance.