#Iso 13485:2012 iso
ISO 13485:2012 can help an organization to express its ability to provide medical devices related services and commitment to quality that continuously meet customer requirements and regulatory requirements applicable to medical devices. La norma ISO 13485 definisce i requisiti per i sistemi di gestione per la qualit i quali permettono all’organizzazione di fornire dispositivi medici conformi alle richieste del mercato e ai requisiti regolamentari che si applicano a tali dispositivi medici. The boxes made by Pegaso Box follow a production process carried out entirely inside the firm in La Valletta Brianza, ensuring the product to be. ISO 13485:2012 results in increased efficiency, quality and improved customer services for the requirements of a quality management system. This award certifies that the company Pegaso Box meets the set quality parameters for the production of medical devices for transport, storage and sterilization of medical devices. Main aim of ISO 13485:2012 is to harmonize the medical device regulatory requirements and to enhance the credibility of an organization with potential customers. It can also be used for the development production, installation and servicing of medical devices.
Such organizations can be involved in one or more stages of the life-cycle, including design and. The ISO 13485:2012 is an international standard for Quality Management Systems designed for the manufacturing of medical devices. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
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