Solsta design and manufacturing facilities in Weymouth and Pangbourne have been awarded ISO 13485:2016 accreditation.

This certification is recognised across the world as a mark of quality and competence. It specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Tony Downer, Chief Technology Officer at Solsta comments: “The medical sector requires the utmost precision and rigour, where the highest quality standard in medical devices is not just expected, it’s essential.  For Solsta, this accreditation is not just a tick box exercise – it’s a reflection of our team’s longstanding and relentless commitment to technical excellence. It underscores the exceptional skillset and best practices that are both a core part of the way we operate.”

“Whilst it is business as usual for our specialist design team, the accreditation will provide us with a catalyst that enhances our capacity to offer unmatched service and expertise.  It serves as a gateway, enabling us to bring our technical innovation to a broader global audience.”

Solsta has over 35 years’ experience in the medical sector, and the team has completed a diverse range of successful projects over that period. This accreditation recognises the high standard the business has been operating at throughout, formalising the team’s skillset and capabilities and providing an enhanced level of assurance to customers and partners.


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