The certification serves as independent verification that the firm’s quality management systems meet rigorous international benchmarks. For clients, this provides a formal assurance that design, development, and manufacturing processes align with the stringent requirements necessary for commercialization. The accreditation arrives as the company seeks to expand its footprint in the competitive medical technology sector.
Salt Medical Secures ISO 13485 Certification in Galway
Salt Medical has achieved ISO 13485:2016 certification, an internationally recognized standard for quality management systems within the medical device industry. This milestone validates the company’s internal protocols, positioning the Galway-based CDMO to better support innovators navigating the complexities of highly regulated global healthcare markets.
Yuqi Shaughnessy, Managing Director of Salt Medical, stated that the certification formalizes the high standards the organization has maintained since its inception. By reinforcing these robust processes, the company aims to offer partners greater confidence as they scale from initial concept to full-scale production. Situated within Galway’s established MedTech cluster, Salt Medical continues to leverage this infrastructure to accelerate the delivery of innovative devices to market.
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