ISO 13485

ISO 13485

What is "ISO 13485:2016"?

ISO 13485:2016 is an international certificate which has specific requirements for medical equipment and related services.

Manufacturers and producers of medical equipment need to achieve ISO 13485 to establish and maintain the effectiveness of their processes. Therefore, they ensure the consistent design, development, production and costumer satisfaction.

This standard states out the quality management of an organization which produces medical equipment and devices. This standard shows that the organization is capable of manufacturing these devices, supporting the costumer rights and respecting the related legal requirements for their services. The main purpose of this standard is to facilitate the compatibility of the device with the mentioned requirements.

ISO 13485 is the world’s most general standard system which determines the requirements of a quality system for production, sales, development and services. Their goal is assisting in research and development purposes, design process, improvement and development of medical equipment.

 Aminbic Company is proud to receive this certificate. Hence, all the products of this company are produced meeting the requirements of it.

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