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Salt Medical Secures ISO 13485 Certification in Galway

Galway-based Salt Medical has secured ISO 13485:2016 certification, marking a pivotal step in the firm’s expansion as a full-lifecycle partner for medical device developers. The accreditation provides independent validation of the company's quality management systems, essential for navigating the stringent regulatory requirements of the global healthcare market.

Salt Medical Secures ISO 13485 Certification in Galway
Photo: Bio & News

The certification confirms that Salt Medical’s internal processes for design, development, and manufacturing align with internationally recognized benchmarks. By formalizing these quality standards, the firm aims to bolster its role as a Contract Development and Manufacturing Organisation (CDMO), assisting innovators from the initial concept phase through to full commercialization.

Yuqi Shaughnessy, Managing Director at Salt Medical, noted that the milestone validates the high operational standards the company has maintained since its inception. For clients, the move serves as a safeguard, ensuring that manufacturing operations and quality management systems are robust enough to withstand the complexities of modern medical technology regulation. Located in one of Europe’s primary MedTech hubs, the company expects this development to accelerate its growth strategy and increase its capacity to support global partners in bringing new technologies to market.

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