Full registration cycle with Roszdravnadzor and EAEU: from dossier preparation to expert evaluation support. 1,000+ certificates issued, zero rejections since 2019.
Six service lines cover the full regulatory lifecycle — from initial classification to defending the dossier at expert evaluation.
We compile the full documentation set in accordance with Government Decree No. 1416 and EEC Decision No. 46. Operational documentation, safety justification, and risk management per ISO 14971.
Initial audit of documentation, determination of risk class and medical device type code, selection of registration strategy.
Specifications, manuals, risk management file, medical software validation.
Selection of laboratories, technical, toxicological, clinical tests.
Implementation of QMS from scratch, production audit, ISO 13485, CE marking.
Full cycle of registration of medical devices of all risk classes, submission through the EPGU, interaction with Roszdravnadzor.
GMP audits to ISO 13485, FBU inspection support, and authorized representation for foreign manufacturers filing with Roszdravnadzor.
Hub for all projects: regulator liaison, testing coordination, and dossier expertise support.
South China tech park: primary manufacturing zone for electronic and in vitro devices destined for Russia.
QMS audit support and adaptation of European MDR dossiers to Russian and EAEU requirements.
Italy is the centre of expertise for implants and cardiovascular devices, with ISO 13485 audits for Russian submissions.
Israeli startup clusters are the main source of SaMD and AI diagnostic systems being registered in Russia.
Boston biotech cluster: we convert FDA-cleared devices into Russian registration certificates via the 510(k)-equivalent route.
Operational geography map. Equirectangular projection.
Figures are updated quarterly based on the Roszdravnadzor registry and internal project statistics.
Seven clearly defined stages with fixed timelines, milestones, and a dedicated project manager at every phase.
Get a plan tailored to your deviceDevice analysis, risk classification, routing — Russia or EAEU — dossier composition, timelines, and cost.
Systematic review of existing documents — fixed price, fixed timeline, defined deadlines. No hidden fees.
Technical specifications, product passport, instructions for use, and testing program — in compliance with GOST R and EAEU requirements.
Placement in an accredited laboratory. Protocol oversight, non-conformity handling, and re-testing as needed.
Biocompatibility per ISO 10993. Cytotoxicity, sensitization, irritation, and systemic toxicity.
Literature review, clinical data analysis, and a regulator-grade CER report.
Preparing responses to deficiencies, defending the application, and revising documentation. We see the case through to issuance of the Registration Certificate.
A selection of 2024–2025 projects, from diagnostic equipment to Class 3 implantable devices.
The registration certificate was received without a single request for revision. The manufacturer entered the register of the …
The registration certificate was received in 6 months - 30% faster than the market average. The device was …
The registration certificate has been received. This is one of the first precedents for registering SaMD of this …
Medical device registration is a highly specialized field. Compare the approach of a dedicated regulatory firm with standard legal services.
If your case is non-standard, submit your question via the form below and we will respond within 24 hours.
We'll name the risk class, choose national or Eurasian route, list required tests and time to certificate.