— Services — Registration of Medical Devices in Russia and the EAEU — Preparation and Support During Inspections

A production inspection verifies both the documented implementation of the QMS and actual production processes. It can be an overwhelming process due to the documentation volume and language barriers.

An on-site inspection is a mandatory step in the registration of complex medical devices. It is required for Class IIa (sterile), IIb, and III medical products. We help manufacturers (both Russian and foreign) prepare their Quality Management System (QMS) for inspection by the regulator. Our goal is to bring your production processes into full compliance with regulatory standards.

On-site or remote service to assess production readiness for the initial inspection (internal audit) (recommended for manufacturers who have recently implemented a QMS)

The in-person or remote presence of our experts during the commission’s visit to facilitate the process and protect the client’s interests