#Ireland #Medical Devices #Galway #ISO 13485 #Salt Medical

Salt Medical Achieves ISO 13485 Certification

In a significant milestone for the medical device industry, Salt Medical has officially attained the ISO 13485:2016 certification. This internationally recognized standard upholds quality management systems specifically tailored for the medical device sector, portraying Salt Medical's dedication to excellence in all offerings.

Achieving this certification is more than a mere acknowledgment; it embodies Salt Medical's relentless commitment to quality assurance and regulatory adherence. It marks a pivotal moment in the organization's journey, ensuring that they meet globally recognized standards for their quality management system. This achievement enhances Salt Medical's capacity to assist medical device innovators, particularly those navigating the complexities of heavily regulated environments.

As a comprehensive Medical Device Contract Development and Manufacturing Organization (CDMO), Salt Medical supports clients from the initial concept to the effective commercialization of products. Their capabilities encompass expertise in design, development, manufacturing, and commercial readiness, all essential for expediting the launch of innovative medical technologies. The attainment of the ISO 13485 certification further fortifies these offerings by ensuring that their underlying quality systems and processes are robust and reliable.

Yuqi Shaughnessy, Managing Director of Salt Medical, stated, "Securing ISO 13485 certification is a significant achievement that formalizes the high standards we've consistently upheld. More crucially, it provides assurance to our clients that they are collaborating with a partner devoted to maintaining the utmost levels of quality and compliance. As we venture into growth, this certification enhances our capability to assist medical device companies from concept through to market introduction, solidifying our role as a trusted partner throughout the product lifecycle."

The presence of ISO 13485 certification offers significant reassurance to organizations operating in increasingly regulated markets. By aligning its processes and quality systems with internationally acknowledged standards, Salt Medical distinguishes itself as a reliable entity within the industry landscape.

This achievement is not just a testament to Salt Medical's exceptional processes, but it also reinforces its growth strategy. It enhances the company’s ability to cater to clients amid rapidly changing regulatory landscapes and aids in accelerating the development and commercialization of cutting-edge medical technologies.

Strategically located in Galway—one of Europe’s preeminent MedTech clusters—Salt Medical is dedicated to ongoing investment in its workforce, competencies, and infrastructure. This commitment paves the way for supporting the diverse and evolving needs of the global medical device industry.

About Salt Medical

Salt Medical is a global full-service CDMO, specializing in supporting medical device companies from idea formation to market launch. By combining its expertise across design, development, and commercial readiness, Salt Medical excels at facilitating the swift advancement of medical technologies, harnessing its capabilities to scale manufacturing effectively and ensure compliance within regulated healthcare frameworks.

For further information, please contact:
Karen Flanagan
Marketing Manager
Salt Medical
Email: [email protected]