ISO 13485 Standrad Resource Management requirement
ISO 13485 Standard - 6.3 Infrastructure E-mail

Infrastructures are the stock of the basic facilities and equipment needed for the operation of a process or the maintenance, storage, or distribution of a product. It provides the suitable conditions and accessories to perform the appropriate business tasks and functions and assist in achieving the desired conformity of product and service requirements. Thus, it is strongly related to the product and has a direct effect on the quality of the medical devices.

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