Registration Services for medical devices
From device classification under Government Decree No. 1684 to issuance of the Registration Certificate. Each item is a separate card with fixed timelines, scope of work, and cost estimate.
List of regulatory items
Each item is a distinct workstream with fixed timelines, scope, and budget. Open the card to view the full description.
Consulting and preliminary examination
Document audit, risk class and device type code, registration strategy.
Development and execution of documentation
Specifications, manuals, risk management file, medical software validation.
Organization and support of tests
Laboratory selection, technical and clinical trials, toxicological studies.
Preparation for production inspection, QMS, certification
Implementation of QMS from scratch, production audit, ISO 13485, CE marking.
Formation of dossier and state registration
Filing via the state services portal and liaison with Roszdravnadzor for devices of all risk classes.
Post-registration support
Making changes to the dossier, updating documentation.
Services of an authorized representative of the manufacturer
SCP functions for foreign manufacturers, safety monitoring, complaints.
Training and corporate seminars
Seminars on medical device registration, training on QMS and risk management.
Non-standard device? Get a quote within 24 hours
Describe the design and operating principle — we will select the appropriate registration procedure and testing scope for the specific risk class. Response within 24 hours: quote and work plan.