- Заголовок FAQ в блоке: Собрали для вас ответы на самые популярные вопросы об испытаниях медицинских изделий
- Заголовок FAQ на странице: Questions about testing medical devices
- FAQ:
- Вопрос:
We can find a laboratory ourselves. Why do we need your system?, Ответ:
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- end up with a lab that's formally accredited but whose scope is out of date,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.
- Вопрос:
What's wrong with a laboratory that simply "issues a protocol"?, Ответ:
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.
- Вопрос:
What does your Labbroker system do?, Ответ:
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.
- Вопрос:
How do you verify that a laboratory actually has the right to run the needed tests?, Ответ:
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."
- Вопрос:
Can we use a laboratory we've already worked with before?, Ответ:
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.
- Вопрос:
Why can't we just go to the nearest accredited laboratory?, Ответ:
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.
- Вопрос:
How long does it take you to select a laboratory?, Ответ:
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.
- Вопрос:
We can find a laboratory ourselves. Why do we need your system?, Ответ:
- Оффер:
Laboratory Testing of Medical Devices
Select an accredited laboratory via the free LabBroker service and manage the entire process online. Transparent comparison, seamless integration with logistics, and deadline control — all within a single KREDO platform.Consult an expert
