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

Salt Medical Achieves ISO 13485 Certification

On June 30, 2026, Salt Medical announced a major milestone by obtaining the ISO 13485:2016 certification, a prestigious international standard in the medical device industry. This achievement underscores the company’s unwavering commitment to quality and its dedication to supporting innovators in the medical sector from the initial concept stage through to market launch.

A Commitment to Quality

The ISO 13485 certification validates Salt Medical's quality management system, indicating that it meets internationally recognized standards. This not only reflects the company’s ongoing commitment to regulatory compliance but also enhances its capabilities in supporting medical device innovators navigating heavily regulated markets. With this certification, Salt Medical stands out as a reliable partner, empowering clients to accelerate their projects and streamline their processes while ensuring the highest quality standards.

According to Yuqi Shaughnessy, CEO of Salt Medical, "This certification is a significant milestone for Salt Medical as it officially validates the high standards we have always set for ourselves. It gives our clients confidence that they are working with a company dedicated to maintaining strict standards in quality, compliance, and continuous improvement."

Supporting Innovation in Medical Technology

As a full-service Contract Development and Manufacturing Organization (CDMO), Salt Medical supports clients through critical stages such as design, development, manufacturing, and regulatory approval. By achieving ISO 13485 certification, the company solidifies its position in this sphere, ensuring that its services are built on a foundation of robust quality systems and processes.

This certification also strengthens Salt Medical’s ability to assist medical technology firms as they navigate complex regulatory environments, facilitating the development and commercialization of innovative medical technologies. As an integral player within one of Europe’s premier MedTech clusters, Galway, Salt Medical continues to invest in its workforce, capabilities, and infrastructure to meet the evolving demands of the global medical device market.

Growth and Future Prospects

The certification supports Salt Medical's strategic goals for growth, enhancing its capacity to cater to customer needs in a rapidly changing regulatory landscape. This achievement allows the company to maintain its role as a trusted partner throughout the entire product lifecycle.

Salt Medical is dedicated to helping clients scale their manufacturing processes and bring pioneering technologies to market within regulated healthcare settings. By adhering to ISO 13485 standards, the company ensures its operations are aligned with best practices, reinforcing its commitment to advancing healthcare innovation while prioritizing patient safety and product efficacy.

Salt Medical’s comprehensive approach to service, ensuring quality at every point of the development process, is essential for today’s medical device companies seeking to innovate in a highly competitive environment. With its ISO certification, Salt Medical continues to set a benchmark for excellence in the industry, providing assurance that its operations meet the highest standards of quality and safety.

As the medical device sector continues to evolve, firms like Salt Medical are crucial in supporting innovators who strive to enhance patient care and outcomes through technological advancements. This certification not only validates past achievements but also positions Salt Medical favorably for future growth and expansion within the vital medical device field.