ISO 13485 is a management system standard for companies that are involved in medical device design, manufacturing, storage, sale, repair and maintenance. The ISO 13485 certificate is not only an organization's compliance guarantee of rules and obligations in the field of medical devices manufacturing, but also the basis for obtaining MDR, CE-mark, AIMDD and IVDD. The ISO 13485 system proves not only the medical devices production reliability, but it is an integral part of the market development process in the EU countries, Japan, the USA, China and others.
How else can the ISO 13485 help you:
The ISO 13485 certificate allows you to increase the trust of partners and customers in you, because it is recognized all over the world. The ISO 13485 certificate proves that your company takes the business seriously, including customers’ satisfaction.
ISO 13485 allows you to improve your work with a process approach that makes it easier to find opportunities for development. You will be able to identify and eliminate losses within and between the processes, to reduce errors and avoid rework, which contributes to increasing efficiency and cost saving.
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