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 customer 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 customer 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 to assist 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 to meet the requirements of it.