Artur Belokhvostov

Consulting company
for medical device registration Medrelic.

Services:

• Registration of medical devices according to Russian Federation regulations
• Registration of medical devices in the EAEU
• Accelerated registration
• Amendments to the registration dossier and certificate for a medical device with expert review
• Amendments to the registration dossier and certificate for a medical device without expert review
• Post-Market Clinical Monitoring Report
• Clinical Trials of Medical Devices
• Consultations on the Handling of In Vitro Diagnostic Medical Devices
• Preparation for Inspection of Medical Device Manufacturing Facilities
• Authorized Representative of the Manufacturer (ARM)

More information about:

• Medical device design and development
• Medical device production and inspection
• Authorized manufacturer's representative
• Collection of registration dossier documents - import and testing
• Medical device registration process
• Amendment of registration dossier documents
• Corrective and preventive actions, consumer communications, clinical monitoring
• Cancellation of state registration of a medical device