Salt Medical Achieves ISO 13485 Certification: A Milestone in Medical Device Lifecycle Support
In a significant advancement for its operations, Salt Medical has announced the successful acquisition of ISO 13485:2016 certification, the international standard that governs quality management systems in the medical device sector. This achievement underscores Salt Medical's unwavering commitment to quality and its role as a pivotal partner throughout all stages of the medical device lifecycle, from initial design to market introduction.
This certification not only marks a major milestone in the company's development but also highlights its continuous commitment to regulatory compliance and quality improvement. It serves as an independent verification that Salt Medical's quality management system adheres to international standards. Consequently, this bolsters the company's ability to support medical device innovators operating in highly regulated environments, providing them the assurance needed in a competitive market.
As a Contract Development and Manufacturing Organization (CDMO) specializing in medical devices, Salt Medical provides a comprehensive range of services including design, development, manufacturing, and commercialization. The ISO 13485 certification further strengthens this offering by establishing rigorous quality systems and processes that are integral to the services it provides. According to Yuqi Shaughnessy, Chief Executive Officer of Salt Medical, "Achieving ISO 13485 certification is a significant milestone for us; it formalizes the high standards we have always set for ourselves. More importantly, it assures our clients that they are partnering with an organization dedicated to upholding the strictest standards of quality and compliance."
This certification reinforces Salt Medical's capability to guide medical device companies through increasingly regulated landscapes, assuring that their processes, quality systems, and manufacturing operations meet international norms. The achievement not only aligns with Salt Medical's ongoing growth strategy but also enhances its potential to assist clients in navigating complex regulatory challenges—facilitating the development and commercialization of innovative medical technologies.
Located in Galway, one of Europe’s key hubs for medical technology, Salt Medical is continuously investing in human resources, expertise, and infrastructure to meet the evolving demands of the global medical device sector. Its comprehensive service portfolio equips clients to accelerate product development, scale production, and successfully bring innovative technologies to market amidst stringent regulatory requirements.
About Salt Medical: Salt Medical is a global Contract Development and Manufacturing Organization (CDMO) focused on medical devices, offering an extensive range of services from design to commercialization. Combining expertise in product design, development, manufacturing, and market readiness, Salt Medical empowers companies in the medical device industry to expedite their development processes and successfully navigate the path to market with cutting-edge technologies in highly regulated environments.
This certification not only marks a major milestone in the company's development but also highlights its continuous commitment to regulatory compliance and quality improvement. It serves as an independent verification that Salt Medical's quality management system adheres to international standards. Consequently, this bolsters the company's ability to support medical device innovators operating in highly regulated environments, providing them the assurance needed in a competitive market.
As a Contract Development and Manufacturing Organization (CDMO) specializing in medical devices, Salt Medical provides a comprehensive range of services including design, development, manufacturing, and commercialization. The ISO 13485 certification further strengthens this offering by establishing rigorous quality systems and processes that are integral to the services it provides. According to Yuqi Shaughnessy, Chief Executive Officer of Salt Medical, "Achieving ISO 13485 certification is a significant milestone for us; it formalizes the high standards we have always set for ourselves. More importantly, it assures our clients that they are partnering with an organization dedicated to upholding the strictest standards of quality and compliance."
This certification reinforces Salt Medical's capability to guide medical device companies through increasingly regulated landscapes, assuring that their processes, quality systems, and manufacturing operations meet international norms. The achievement not only aligns with Salt Medical's ongoing growth strategy but also enhances its potential to assist clients in navigating complex regulatory challenges—facilitating the development and commercialization of innovative medical technologies.
Located in Galway, one of Europe’s key hubs for medical technology, Salt Medical is continuously investing in human resources, expertise, and infrastructure to meet the evolving demands of the global medical device sector. Its comprehensive service portfolio equips clients to accelerate product development, scale production, and successfully bring innovative technologies to market amidst stringent regulatory requirements.
About Salt Medical: Salt Medical is a global Contract Development and Manufacturing Organization (CDMO) focused on medical devices, offering an extensive range of services from design to commercialization. Combining expertise in product design, development, manufacturing, and market readiness, Salt Medical empowers companies in the medical device industry to expedite their development processes and successfully navigate the path to market with cutting-edge technologies in highly regulated environments.
Topics Health）
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