Document Package Audit
Free preliminary document review. Fast dossier preparation supported by our proprietary AI system and expert team.
KREDO
International Communications
A digital ecosystem for the registration of medical devices under national regulations of the Russian Federation and the EAEU — fast, transparent, turnkey.
- Knowledgeexpertise in logistics, testing, and medical device registration
- Registrationfrom product samples to complete documentation within a unified ecosystem
- Ecosystemincludes the LabBroker service and partner logistics companies
- Documentationfast and error-free, using advanced technological solutions
- Optimizationregistration processes on average 40% faster and more predictable
Download the presentation: 
Consult an expert
Conduct a self-audit of your documentation package online →
Registration of Medical Devices with Roszdravnadzor — a complex, multi-stage process regulated by federal laws, Ministry of Health orders, and EAEU requirements.
KREDO International Communications — is not just a service or agency, but an intelligent system that redefines the entire architecture of medical device registration in Russia and across the EAEU.
Schedule an online meetingTo bring your product to market, you need to:
- undergo document expertise;
- complete laboratory and clinical testing;
- prepare a comprehensive document package;
- and finally, obtain the registration certificate.
We transform the medical device registration process:
We provide a free preliminary audit of your document package, automate routine tasks using AI technology, and offer a convenient LabBroker service for selecting accredited laboratories and organizing sample logistics — helping you complete registration faster, easier, and with confidence in the result.
We are members of the Moscow Chamber of Commerce and Industry (MCCI).KREDO's Digital Ecosystem
Document Analysis and Preparation
A free preliminary document package audit via our AI chat-bot. Accelerated dossier preparation by experienced experts using KREDO’s proprietary AI solution.
Laboratory Selection
A unique, free online service for selecting accredited laboratories — LabBroker. Compare terms (timelines, costs, methodologies). Transparency at every stage.
Sample Delivery
Organization of sample transportation across Russia and internationally, with full compliance to temperature control, customs clearance, and all formal requirements.
KREDO works with companies of any scale — from startups to international corporations. We ensure fast, accurate, and compliant registration of medical devices.
Russian and international manufacturers and startups
We also actively cooperate with:
- Distributors and brand representatives
- In-house regulatory affairs departments of large companies
No delays. No gaps. No losses. Simply — seamless.
KREDO’s mission — is not just to prepare documents — but to build a complete route for launching your product to market.
We take full responsibility for the strategy and end-to-end registration process, allowing you to focus on your product — not on bureaucracy.
1
2
Transparent Cost
We develop a timeline and cost estimate, agree on all terms, and sign the contract.
3
Sample Delivery
Organization of sample logistics (including international). Fast, compliant, and reliable.
4
Testing
Selection of accredited laboratories via the free LabBroker online service.
5
Dossier Review
Final audit and submission of documents to Roszdravnadzor.
6
Registration Certificate Issuance
Obtaining the RU certificate. If Roszdravnadzor requests clarifications — we prepare responses and accompany the process until full approval.
Yesterday, medical device registration was a long and non-transparent process:
- Unclear timelines and stages;
- Large and vague budgets, additional expenses;
- Fragmented contractors;
- Documentation errors leading to delays;
- Idle time and process interruptions;
- Complicated sample logistics;
- Mistakes when choosing laboratories;
- Frequent revisions and resubmissions.
The main problem — lack of a single responsible party for the entire registration process. When control is spread across multiple participants, timelines shift, and companies face financial and time losses
Today, with KREDO, it’s a transparent and controlled process:
- Transparent subscription model: one contract – one result (from 100,000 RUB/month)
- Step-by-step structure: clear workflow and regular feedback;
- Unified ecosystem: documentation, testing, logistics — all in one;
- Parallel processes and faster sample logistics;
- Accelerated registration process ~ up to 2 times faster;
- Free LabBroker service for selecting accredited laboratories;
- Free preliminary document audit via AI chat-bot;
- Accelerated dossier preparation supported by our proprietary AI system.
We design the full regulatory trajectory of your product toward approval, manage it as a service, and ensure your product’s legal market entry — without barriers or delays.