Currently, the ISO 13485 quality management system certificate is mandatory for all enterprises involved in the production of medical products, including all participants in the MD supply chain and life cycle.
Upon receipt of a registration certificate for medical devices of classes 2a (sterile devices), 2b, 3, Roszdravnadzor sends a special team to an enterprise, which verifies the compliance of production with the current control criteria.
We will help you prepare for inspection control in advance.
What We Will Do for You
First Complex Registration Company offers production support both within the framework of the project for management system development and implementation performed by our consultants and within the framework of systems developed by the enterprise itself or other consultants.
Our Company:
- will help you choose a certification body
- will conduct a pre-certification audit of the system
- will provide support during certification
- will develop a program of corrective actions based on the certification audit results.
In addition, our experts render turnkey services for quality management system implementation at enterprises.
As part of this, we conduct a diagnostic audit of the system, train personnel, design a system for a specific enterprise, develop documentation, support the QMS implementation on site, conduct a final production audit, assist with state registration and, if necessary, provide post-certification support to the company.
All these work stages require the participation of quite a large number of experienced specialists. It is not always the case that a company engaged in the production of medical devices can allocate employees and time for effective preparation for an audit of medical device production by Roszdravnadzor, so using the services of a consulting company can save both money and time.
What Is the Purpose of ISO 13485 Certificate?
ISO 13485 certificate is an international QMS standard that has to ensure the quality of various types of medical devices. It is also used as a tool to admit medical products to circulation. ISO 13485 standard is used as a reference in many countries. In some states, national versions of the quality standard are developed on its basis, but, alas, certificates of national systems are recognized only in specific countries, thereby preventing companies from entering the international market.
Without an ISO 13485 certificate, you will not be able to obtain the CE mark required to enter the European market.
The available certificate is a prerequisite for participation in public procurement, tenders and auctions. It is necessary in order to obtain registration certificates for medical devices according to the EAEU rules and, correspondingly, for inclusion in the state register of medical devices of Roszdravnadzor.
It is valid in more than 70 countries; many countries do not allow MDs from a manufacturer, who has no ISO 13485 certificate into their markets.
Our specialists are ready to answer all your questions and help you decide on further steps — from implementing the ISO 13485 standard to obtaining a registration certificate and entering your product into the register of medical devices of Roszdravnadzor.