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What is a GOST ISO 13485-2011 certificate?

Certificate of GOST ISO 13485-2011 is a document that confirms the compliance of the organization's management system with the requirements of GOST ISO 13485-2011, similar to the international standard ISO 13485:2003.

The purpose of this standard is to facilitate the introduction of harmonized established requirements for medical devices into quality management systems.The standard also provides full openness and accessibility of processes regulating the treatment of medical devices.

GOST ISO 13485-2011 standard defines the requirements to the quality management system, which can be used by an organization in the design, development, production, installation and maintenance of medical devices and related services. This standard may also be applied internally and externally to an organization by stakeholders, including certification bodies, to assess the organization's ability to meet customer requirements and the requirements established in accordance with regulatory documents.

ISO 13485 is focused on medical devices and related services, and therefore contains many requirements that affect different areas of the industry, such as storage space requirements, hygiene of personnel, equipment and facilities, and the mechanism for product recall from the market. 

Companies for which it is expedient to implement GOST ISO 13485-2011:

- organizations producing medical equipment and products under a private brand and wishing to place their products independently in the EU markets;

- organizations involved in the design of medical equipment;

- organizations developing software for medical equipment;

- organizations that produce medical device components.

If you need to get a GOST ISO 13485-2011 certificate, you can apply to the company "SMK STANDART" for help. Specialists of the company with many years of experience in certification will help you to collect the necessary documentation and pass all stages of the certification procedure.


Автор - Ульяна

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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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