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Support of production audit and implementation of QMS

Support of production audit and implementation of QMS

According to the national rules for registration of medical devices and the rules for registration in the Eurasian Economic Union (EAEU) the presence of a quality management system (QMS) at an enterprise that meets the criteria of the GOST ISO 13485 standard is mandatory for manufacturers of medical devices of risk classes 2a sterile, 2b and 3, and recommended for manufacturers of medical devices of risk classes 1 and 2a non-sterile.

Quality management system

This is a set of organizational structures, processes, methods and resources that are needed to ensure the consistent quality of manufactured products.

More details
The Production Audit Report within the framework of registration is carried out by the Expert Organizations of Roszdravnadzor.
Our team assists with audit preparation to ensure the inspection visit proceeds quickly and with minimal additional requests:
Selecting an expert organization
Filling out an Application for an Audit to an Expert Organization
On-site support during an expert organization audit
Consultation on preparing the manufacturer for an expert inspection, a list of questions and documents requested by the expert organization
Need a consultation?

Request a free consultation on the registration procedure 
and ask all your questions.

It is intended to continuously improve the quality of work
and increase the competitiveness of the enterprise in the domestic and global markets.

We develop a detailed registration plan in collaboration with the manufacturer or authorized representative and provide timely information on potential risks and necessary actions to ensure compliance with the schedule;

Request for consultation

Leave your contact information and we will contact you to clarify the details of your application.