, /PRNewswire/ — Salt Medical today announced it has achieved ISO 13485:2016 certification, the internationally recognised standard for quality management systems for the medical device industry.
The certification marks a significant milestone in the company’s growth and reflects its ongoing commitment to quality, regulatory compliance and continuous improvement. It provides independent verification that Salt Medical’s quality management system meets internationally recognised standards, further strengthening the company’s ability to support medical device innovators operating in highly regulated environments.
As a full-lifecycle Medical Device CDMO, Salt Medical supports customers from concept through to commercialisation, providing expertise across design and development, manufacturing and commercial readiness to help accelerate the delivery of innovative medical technologies. Achieving ISO 13485 certification further enhances this offering by reinforcing the robust quality systems and processes that underpin the company’s services.
“Achieving ISO 13485 is an important milestone for Salt Medical as it formalises the high standards we have always set for ourselves,” said Yuqi Shaughnessy, Managing Director of Salt Medical.
“More importantly, it provides our clients with confidence that they are partnering with an organisation committed to delivering the highest standards of quality, compliance and continuous improvement. As we continue to grow, this certification strengthens our ability to support medical device companies from concept through to commercialisation while remaining a trusted partner throughout the product lifecycle.”
For companies operating in increasingly regulated markets, ISO 13485 certification provides additional assurance that Salt Medical’s processes, quality systems and manufacturing operations align with internationally recognised medical device standards.
The achievement also supports Salt Medical’s continued growth strategy, strengthening its capability to support customers as they navigate increasingly complex regulatory environments and accelerate the development and commercialisation of innovative medical technologies.
Located in Galway, one of Europe’s leading MedTech clusters, Salt Medical continues to invest in its people, capabilities and infrastructure to support the evolving needs of the global medical device industry.
About Salt Medical
Salt Medical is a global full-service Medical Device Contract Development and Manufacturing Organisation (CDMO), supporting companies from concept to commercialisation. Combining expertise in design and development, manufacturing and commercial readiness, Salt Medical helps medical device companies accelerate development, scale manufacturing and bring innovative technologies to market within regulated healthcare environments.
Media Contact
Karen Flanagan
Marketing Manager
Salt Medical
[email protected]
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SOURCE Salt Medical
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