FAQ

We don't just register devices — we design and manage the entire regulatory route: from strategy to the final certificate. Unlike the agency model, we build an architecture out of every component: logistics, laboratories, translations, deadline control, regulatory analysis.

And most importantly — we do this using our own system of AI agents that replace manual chaos with algorithmic order. This isn't automation for speed's sake, but systemic thinking for the sake of accuracy and resilience. The result: fewer errors, higher reliability, more control, less time.

Seamless registration means the entire process is built as a single logical structure, with no gaps, no drop-offs, no manual patch-ups, and no losses at the handoff points.

In the old model, documents are prepared by one team, testing is done by another, and logistics by a third — with no connection between them, and every step turning into a mini-crisis. With us, everything is connected: stages are planned in advance, processes run in parallel, and management logic is unified.

Seamlessness means registration stops being a quest. It becomes a predictable trajectory with a guaranteed result.

These are exactly the devices we take on. We have no "economy class" and no "that's just how it has to be here." We work strictly to a standard of full transparency and legal integrity.

The AI agents in our system check not only deadlines and templates, but also compliance with the actual requirements of technical regulations, verify laboratory accreditations, and flag errors before they ever make it into the dossier.

That's exactly why we're trusted with complex, contentious, innovative, and sensitive devices — because we manage risks before they become problems.

We're not building a department — we're building a system. Our infrastructure scales: new projects are added as processes within the operating platform. We calculate load in advance, reserve laboratory slots, and automate routine operations.

Even when we have dozens of routes in progress, every project still gets personal support, while core actions follow a single unified standard.

We don't overload people — we delegate part of the process to the system, and people focus only on what genuinely requires expert attention. That's how we grow without losing quality.

We've developed a model of AI agents where each "agent" isn't a generic chatbot but a narrowly specialized operator: for logistics, accreditation, document workflow, regulatory requirements, protocol verification, risk management.

This system:

• eliminates errors in the dossier,
• flags supply chain disruptions before they happen,
• verifies laboratories,
• suggests the optimal route,
• tracks legislative changes.

 This isn't a "helper module" — it's the nervous system of the entire project. Thanks to AI, we achieve what the manual market simply cannot: stability, speed, predictability.

Great. Then we don't start from scratch — we plug into your current route. The KREDO system can connect at any stage: run an audit, reinforce weak links, finalize the dossier, replace a laboratory, organize logistics, and carry the project to the finish line without setbacks.

You lose nothing at the start. You win at the finish. We're not replacing your work — we're completing it.

The fact that we don't depend on one person's memory, mood, connections, or workload.

The KREDO system:

• never forgets to account for new requirements,
• never submits a protocol from a questionable laboratory,
• never loses a document,
• is never late with logistics,
• never mixes up versions.

We don't compete with good registrars. We offer them a tool that makes their work systematic, protected, and scalable.

We price the launch of the registration route, not a bundle of services. In other words, you don't pay for translations, deliveries, and brochures — you pay to pass every key point of the route correctly, on time, and within the law.

We eliminate duplicate stages, unnecessary manual work, and unreliable contractors. That's exactly why KREDO often ends up cheaper than the traditional approach — especially once you factor in rework, losses, and "unexpected revisions."

We don't have "vague estimates." We have a clear route, a fixed outcome, and transparent pricing.

Yes. KREDO was built for large-scale tasks. From the outset we designed the system to process entire device portfolios, build parallel routes, distribute workload, and manage several regulatory campaigns at once.

We have solutions for large RA departments, corporate teams, and groups of companies. Everything scales — without losing control.

We know how to work solo. But we're especially strong working alongside a client's own strong team.

Because everything we do is a direct answer to the real costs of the manual market:

• lack of transparency,
• repeated errors,
• lab bottlenecks,
• outdated templates,
• lost documents,
• invalid protocols.

We're building an architectural, technological, and scalable standard that the market will adopt as the new norm. Sooner or later, everyone will work this way. We simply started first.

We're not just fitting into the regulatory system — we're helping rewrite its logic, language, and pace. If you're with us, you're inside this transformation. Not outside it.

No. One of KREDO's core principles is to remove the client from operational processes as much as possible — especially something as complex and finicky as sample logistics.

Delivery is handled by a specialized international transport company, proven across hundreds of cases. It picks up samples directly from the manufacturer, in any country, without your team's involvement, without arranging separate powers of attorney, and without you having to find transport. Everything is collected according to instructions and handed over directly to the laboratory.

You don't get lost in customs, you don't arrange packaging, you don't issue invoices. We handle all of it for you — professionally, correctly, and on time.

Because sample logistics is an area of heightened regulatory scrutiny, especially given the crackdown on falsified testing. Even a formally correct sample can be rejected by the lab or blocked at the border if it's poorly packaged or incorrectly documented.

When logistics is handled by an outside person "following instructions," something almost always goes wrong. Our transport company, by contrast, operates along verified routes under strict supervision: samples arrive at the laboratory already in exactly the condition required to begin testing.

This isn't just transportation — it's part of the registration route. Tried, professional, and managed.

We have a contract with a major international transport company that specializes specifically in medical and laboratory cargo. It has experience delivering shipments from China, South Korea, the EU, the US, Turkey, and other countries.

Samples:

• are picked up from the factory or warehouse,
• are documented with our specialists' support,
• clear customs,
• are delivered to Russia,
• and are handed over directly to the laboratory.

We don't use shared shipments or couriers found through classified ads. We build a reliable logistics chain in which every element is under control.

Our team handles everything together with our transport partner. This includes:

• invoices,
• product descriptions,
• instructions in Russian,
• labeling,
• and, where necessary, justification for customs and the laboratory.

We agree on requirements with the laboratory in advance, so there's no "fixing things after the fact." You don't need to get into the details of customs clearance or figure out which HS codes to use.

You simply hand over the product data — everything else becomes a managed logistics flow.

We work with a carrier that's insured and liable for the condition of the cargo. But more importantly, we maintain strict control over the entire route.

Samples are tracked at every stage: from leaving the factory to being handed over to the laboratory. If something goes wrong, we're notified immediately and activate a backup route or arrange a duplicate shipment.

Loss or damage of samples is ruled out as a systemic problem — it's already a solved issue, not a risk the client has to bear.

Before shipping, we compile a single, complete set of documents specifying everything: the name, the device type, serial numbers, testing objectives, cross-references to the dossier, and links to the relevant methods and regulations.

The sample doesn't arrive at the laboratory "anonymously" — it arrives as an element of the registration route. This eliminates the risk of identification errors, mishandling, or rejection.

You won't get a call from the lab asking "What exactly did you send us?" They already know what's coming and why, because logistics is built directly into the regulatory process.

Over the past two years, regulatory pressure has intensified: Roszdravnadzor, the Federal Customs Service, and Rosakkreditatsiya are now watching closely where samples come from, how they're delivered, and who delivers them.

The market is undergoing a hard purge of paper and falsified laboratories. That means any deviation in documents, careless packaging, or incomplete labeling can become grounds for a registration rejection or an on-site inspection.

That's exactly why at KREDO we centralized logistics and removed the client from it entirely. You carry no risk, because we've already calculated it, structured it, and brought it under control.

We're open to anyone who wants to become part of the new technological ecosystem for medical device registration. Right now, we're especially interested in:

• software developers,
• engineers specializing in AI and document workflow automation,
• testing laboratories,
• registrars with a high standard of professional ethics,
• industries and communities of medical device manufacturers,
• and relevant universities ready to take part in transforming the industry.

We don't just bring in outside contractors — we unite strong players into a single architecture, where each one becomes a co-author and co-creator of the new standard.

We're not afraid — we cooperate. Our project doesn't compete on "who can file with the regulator faster." We're building an overarching system in which every process — from dossier compilation to logistics and analytics — is managed architecturally and technologically.

Registrars who know how to do quality work and want to focus on their expertise rather than routine tasks will find reinforcement, support, and a ready client flow in KREDO. Instead of competing for clients, we offer cooperation for the sake of scale.

Today we're giving registrars tools that will become the industry standard tomorrow. Joining now means becoming part of the team that's changing the rules.

Laboratories get:

• a steady flow of projects,
• transparent document workflow,
• advance notice for sample submission,
• correctly prepared accompanying documents,
• and built-in protocol verification through a digital system.

We don't push our mistakes onto the laboratory, don't leave staff without instructions, and don't deal in last-minute "rescues." Everything is clear, planned in advance, and done correctly.

On top of that, the laboratory becomes visible in the market as part of a strong ecosystem — which means trust, new clients, and reputational protection.

We're building a digital architecture capable of processing hundreds of registration routes simultaneously: generating documents, forecasting risks, and updating strategies as new regulations come into force.

We need teams that know how to:

• design reliable backend systems,
• work with regulatory databases,
• apply AI to real-sector tasks,
• and are ready to integrate into the ecosystem, not just write code on commission.

We're not commissioning software — we're inviting people to build infrastructure that will transform the industry. This is a chance to be not a contractor, but the developer of an industry standard.

Yes. We see universities as key partners in building the new registration model. We're already preparing proposals to incorporate elements of our system into educational programs, and we're ready to:

• co-develop courses,
• bring students into internships,
• work together on research and case studies,
• and elevate universities to the status of intellectual co-creators of the project.

 KREDO is not a closed business. It's an open platform that's changing the rules of the game — and universities have one of the most important seats at the table.

First and foremost, a transparent, managed, technological environment for launching new devices. We eliminate regulatory unpredictability, shorten timelines, and protect manufacturers from contractor errors.

Communities get:

• a partner for educational programs,
• a technology provider for their members,
• and the ability to build collective initiatives (themed routes, shared solution libraries, analytics).

 You no longer leave your members to face the system alone. Instead, you connect them to an environment where everything already works — fast, lawful, and safe.

We're striving to create not just a digital service, but a new standard for the regulatory market — open, technological, managed, and fair.

Our goal is to develop an intelligent platform that will:

• design regulatory routes for every device — architecturally, not manually,
• adapt strategies in real time to any change in legislation,
• connect laboratories, translators, logistics providers, and registrars under a single protocol,
• manage hundreds of processes simultaneously, with no failures, conflicts, or paperwork confusion,
• and, most importantly, do all of this transparently for every party involved: manufacturers, RA teams, authorities, and experts.

We're not adapting to the existing rules — we're shaping a model of what those rules should be. Not as a compromise, but as a model for a mature, safe, and scalable market.

Welcome aboard. If you feel you also want to be part of this transformation — you're already in the right place.

Most players in the market operate on old templates: they collect documents by hand, pass files between contractors, follow fixed templates, and only start thinking once problems appear. We, on the other hand, design the entire registration route before we even start — using our own system of AI agents that analyze legislation, check the applicability of approaches, forecast bottlenecks, and build the shortest, most cost-effective, and most resilient trajectory.

Old-school registrars are about "paper, stamp, and wait." KREDO is about systematically launching a device into circulation — with control over deadlines, document workflow, logistics, and testing.

This is exactly how the principle of seamless registration works: every segment of the regulatory route is connected to the others, with no losses, no unnecessary coordination, no timing conflicts. We don't just file paperwork. We manage the process.

Because we have no human bottlenecks. In a typical registration scheme, every stage depends on how quickly one person moves: testing can't start until the logistics person hands over the samples; the dossier can't go out until the translation is laid out. These processes drag on for months.

With us, it's different: AI agents manage the route as a whole. They trigger parallel actions, automatically generate drafts, track the readiness of every element, and remind people of deadlines. This lets us work synchronously instead of sequentially.

The result:

•  registration time cut by roughly 1.5–2x,
•  no more "gaps" between stages,
•  the device reaches the market in the shortest possible time — with no loss of quality.

This is exactly what seamlessness means: the next step is already ready before you even ask for it.

Registration is expensive not because it's inherently complex, but because it's loaded with redundant actions: repeated edits, unplanned translations, incorrect samples, outdated templates. The client pays for all of it.

At KREDO, we eliminate redundancy at the root. Our system of AI agents builds the route right from the start without unnecessary iterations. We don't produce five versions of a translation, because we load the current regulatory requirements from day one. We don't ship samples blindly, because we cross-check test protocols and laboratory requirements first.

The client pays only for what works — for the result, not for the attempts. This saves up to 30% of the budget compared to "manual registrars," especially on projects that hit a dead end and need to be restarted.

Our AI agents don't allow unnecessary work to happen — which is exactly why you don't pay for what doesn't need to be done.

Yes, for most of the market, it is. The process is opaque, contractors aren't coordinated, nobody knows what's happening with the documents, the laboratory goes silent, and the regulator asks for something no one anticipated.

But not with us. KREDO was built specifically as an antidote to chaos. We build a clear, manageable route: you see a project dashboard, receive notifications, and know the status of every stage. You can ask any question, and the AI model gives you an answer tailored to your specific situation, not a generic one.

We call this seamlessness: the project never breaks, never stalls, never loses momentum. You move through the route with no "gray zones." Everything is visible, understandable, explainable. This is the new norm — and we're the first to implement it.

Of course. There are plenty of projects on the market that are "almost at the finish line" but stuck on small things: something's off in the dossier, the translation doesn't match the IFU, the lab won't issue the right protocol. In these cases, most contractors will advise you to "start over."

We, on the other hand, join a project in any state. Our AI system quickly analyzes what already exists, where the errors are, what's missing, and proposes a concrete plan to reach the result. We don't reset to zero — we add to it, correct it, and bring it to a logical conclusion.

This too is seamlessness — we don't tear down what's already there, we integrate into it naturally and carry the route to completion. The client saves time, money, and nerves.

That happens when a project is managed manually and risks are ignored from the start. We rule out that scenario, because every route is built not in a spreadsheet or on hope, but inside a system of AI agents that verify the strategy's applicability, the completeness of the dossier, and compliance with current requirements.

Before your project is submitted to Roszdravnadzor, it goes through a virtual "dry run": we see what could trigger a rejection, where evidence is missing, and which documents need to be strengthened.

This is exactly how the seamless model is built: we don't just travel the road, we check the route in advance — like a navigator that already knows every traffic jam, closed section, and accident.

Because we're already operating as the industry of the future, while everyone else keeps copying practices from the 2010s. We were the first to build an AI infrastructure that doesn't just help — it manages the process. We don't work as an agent; we work as a systemic operator. We don't adapt to the market — we reshape it.

Everyone who looks at us today with interest and skepticism will be copying what we implemented a year ago, tomorrow. But the clients who come to us now get the advantage right here, right now: a faster start, lower costs, higher precision.

We don't just claim "the future belongs to us" — we've turned it into a working model. You're simply arriving in it first.

In theory — yes, you can open the register of accredited bodies, spend several days analyzing accreditation scopes, call around to laboratories, and negotiate terms… And you could still:

• end up with a lab that's formally accredited but whose scope is out of date,
• receive a "paper" protocol that Roszdravnadzor won't accept,
• waste a month and send the project into regression.

KREDO spares you that scenario. We connect the Labbroker system — an intelligent module where AI agents:

• verify laboratory accreditation scopes against Russia's Federal Accreditation Service (FSA) register,
• filter out formal and high-risk players,
• contact laboratories directly, and
• secure a legally sound proposal.

We don't just "look for a lab." We reduce the risk of rejection at the final stage of registration to zero.

In 2024–2025, the market began actively cleaning itself up. Rosakkreditatsiya, Roszdravnadzor, and the prosecutor's office are now checking every link in the chain: whether a real sample existed, who signed the protocol, and which methods were used.

If a laboratory comes under inspection and your protocol is one of the ones it issued, you risk:

• registration being suspended,
• the protocol being declared invalid,
• the dossier being returned,
• and even administrative liability.

With KREDO, you only work with laboratories that are legally accredited, genuinely perform the testing, and raise no questions with regulators.

Labbroker is an intelligent broker for laboratory solutions. It's run by AI agents and:

• analyzes your product,
• determines which tests are required under the regulations,
• finds laboratories capable of performing them,
• verifies their accreditation against the FSA register,
• obtains official confirmation of testing availability,
• and reserves a slot for submitting samples.

This saves you hours of manual searching and weeks of waiting — and most importantly, it protects you from hidden errors that would otherwise surface only at the registration stage.

We don't take anyone's word for it, and we don't work off a phone call. Our AI module pulls the laboratory's accreditation scope from the official FSA register and cross-checks the codes against the current requirements of the technical regulation.

If even one code is missing, the laboratory is excluded from the route. We also check when the accreditation was issued, and whether there have been any suspensions, technical violations, or cases of revoked protocols.

You don't need to verify anything manually — we do it automatically, based on primary sources, not on "recommendations."

Yes, but only if it meets the route's requirements and passes verification. We don't force our own pool of laboratories on you, but we also won't take responsibility for a choice made outside the system.

If the laboratory is willing to work transparently, has a valid accreditation scope, and reasonable turnaround times, we integrate it into the route through Labbroker. Otherwise, we'll propose an alternative.

What matters isn't convenience — it's the legal soundness of the results. Registration is not the place for compromises.

Because accreditation ≠ the right to run a specific test. Accreditation can be:

• purely formal,
• missing the required methods,
• outdated, or
• temporarily suspended.

On top of that, a laboratory may lack the resources to run the tests on time, lose the samples, fill out the protocol incorrectly, or expose you to regulatory risk.

Proximity isn't the criterion. We choose based on reliability, verification, and safety — not convenience.

Depending on the type of device — from 1 to 3 business days. Our AI agent processes the request, analyzes the regulation, sends out inquiries, collects the responses, and produces a well-founded choice. You don't need to make calls, write letters, or cross-check codes manually.

In the typical model, selecting a laboratory takes weeks and delivers an unstable result. With us, it's a digital operation with a controlled outcome, built directly into the registration route.

You don't waste time searching. You get a solution — safe, documented, and transparent.