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GOST R 13485-2004 certification for foreign companies

“SMK STANDART” Company offers to foreign manufacturers and suppliers of medical devices to issue GOST R 13485-2004 certificate which is similar to ISO 13485:2003. This document confirms compliance quality management system of your company with GOST R 13485-2004 (ISO 13485:2003) requirements. The requirements to quality management system set out in this standard are additional to technical requirements for products. Herewith, compliance with the standard ISO 13485:2003 is not mandatory and it may be issued voluntarily using services of “SMK STANDART” specialists.

GOST R 13485-2004 main provisions are based on ISO 9001:2008 requirements. Therefore, since it completely dedicated to medical devices and related services, it contains plenty of new requirements affecting different areas of the industry, such as: storage facilities requirements; demands to hygiene of staff, equipment and locations; recall procedures of product which has negative impact on human health.

GOST R 13485-2004 (ISO 13485:2003) is based on eight quality management principles:

- customer focus,
- leadership,
- personnel involvement,
- process approach,
- system approach to management,
- continuous improvement,
- factual approach to decision making,
- mutually beneficial supplier relationship.

What does GOST R 13485-2004 (ISO 13485:2003) certificate of conformity provide:

• Observing the licensing conditions, meeting the requirements for medical devices certification;
• Implementing the terms of medical devices export;
• Advantages in participation in various tenders, competitive biddings, state procurements;
• Increasing customer's loyalty;
• Increasing loyalty of supervisory authorities;
• Improving the company's image as a reliable supplier;
• Increasing company's market value;
• Increasing company's investment attractiveness.

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How to receive the certificate?

The applicant provides to the certification bode «SMK STANDART» the filled application form for obtaining the certificate by means of filling of a form on our site.

If you have additional questions – contact our specialists by phone +442035146935.

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