Describe your device and within 24 hours we will assign the risk class under Government Decree No. 1416, define the regulatory pathway, and estimate timelines and cost. We accept inquiries by phone, e-mail, Telegram, and via the form below.
GMP inspections, documentation audits, and localization of the registration dossier for the Russian Federation and the EAEU across six jurisdictions.
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.
Full company details for contracts and invoices. NDA available upon request.
Risk class, registration pathway, list of required tests, and time-to-RC — all in a single email.