Clear answers for regulated teams building from day one.

nianav OS is an operating system for regulated startups. It gives teams one connected place to run procedures, assign work, capture evidence, manage records, and see what is happening across the company.

It is built for startups and scaleups working in regulated industries, especially medtech, health AI, biotech, and other companies where evidence, traceability, quality, and audit readiness matter from the beginning.

Starting a regulated company is not like starting a normal company. There are rules to the game, and many founders only discover them when something becomes expensive: an audit, a submission, a clinical milestone, an investor diligence process, or a quality issue. nianav OS helps put the scaffolding in place earlier, so the company grows with structure instead of trying to rebuild it later.

No software can honestly promise that on its own. Compliance still depends on the company, the product, the decisions made, and the evidence produced. What nianav OS does is make the work easier to structure, trace, review, and prove. It helps teams operate in a way that supports compliance instead of scrambling to reconstruct it afterwards.

It solves the fragmentation problem. In many regulated startups, procedures live in documents, evidence lives in folders, decisions live in email, tasks live in project tools, and knowledge lives in people's heads. nianav OS connects the work to the evidence as it happens.

It includes important QMS capabilities, but it is broader than a traditional QMS. nianav OS is designed as an operational fabric: quality, operations, projects, training, change control, compliance evidence, and AI governance all run from the same connected system.

Those tools can work early on, but they usually become stressful as the company grows. They do not naturally know which procedure created which record, who approved what, what evidence supports a requirement, or whether the latest version of the process is actually being followed. nianav OS is built around those relationships from the start.

Project Zero is the setup process that helps a new company get its operating scaffold in place. Instead of starting from a blank system, the company is guided through the procedures, records, roles, and regulatory scope it needs to begin operating in a more controlled way.

Earlier than most teams expect. The best time is before the company has accumulated months of undocumented decisions, scattered evidence, and informal workarounds. If clinical work, product development, quality processes, AI use, supplier work, or regulatory submissions are on the horizon, the structure should already be forming.

It helps by linking evidence to the work that produced it. Requirements, risks, tests, decisions, reviews, changes, and records can be connected instead of stored as separate fragments. That makes it easier to understand what has been done, what still needs proof, and what can be shown during review or audit.

Not always. Some specialist tools should stay specialist: CAD, GitHub, Microsoft 365, e-signature tools, lab systems, or other domain-specific platforms may remain external. nianav OS is designed to connect the operating and evidence layer around them, so the company can still understand the full picture.

nianav OS treats AI as something that needs governance, not as a magic feature. AI-assisted work should have a defined scope, a responsible human, version control, evidence, and an audit trail. That matters because regulated companies need to know not only what AI produced, but how it was used and who was accountable.

The goal is the opposite. Regulated work already exists; the question is whether it is captured clearly or reconstructed under pressure later. nianav OS is designed to make the right way the easier way, so evidence is created during normal work rather than as a separate panic project before an audit.

Niavicta was started by two compliance professionals with two and a half decades of experience across medtech and regulated industries. They kept seeing the same avoidable setbacks: good teams, good ideas, but disconnected systems and late evidence. nianav OS was built to give founders a clearer path from day one, so regulation becomes less of a hidden burden and more of a lever for getting strong products to market.