End-to-End Development for Medical Devices
ISO 13485-certified design, development and contract manufacturing services for medical devices and in vitro diagnostics. One partner. Every step.
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One Partner. Every Step.
One Partner. Every Step.
We specialise in helping early-stage teams and established companies bring complex medical devices and in vitro diagnostics to market. Whether you're developing a diagnostic platform or lab automation system, we manage the process from start to finish. Our multidisciplinary team works closely with your team to make sure the path from concept to market-ready is clear, efficient and risk-managed.
Our Services
Our Services
Early-stage concept development for regulated medical devices, balancing usability, feasibility and compliance.
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System refinement and rapid prototyping to accelerate clinical validation or manufacturing readiness.
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ISO 13485-certified small-batch and pilot manufacturing in the UK and USA, with scalable production support.
Post-market services including calibration, repairs and functional testing to maintain device performance and compliance.
Why XT Biomed?
Why XT Biomed?
ISO 13485-certified Quality Management System
Multidisciplinary engineering team with hands-on experience
End-to-end service, from concept to market-ready
Specialists in biological sample handling
UK and US facilities with international project delivery
Flexible, customer-focused approach
ISO 13485-Certified Development & Manufacturing
ISO 13485-Certified Development & Manufacturing
XT Biomed operates a fully certified ISO 13485:2016 Quality Management System, ensuring every product meets rigorous international standards for quality, safety, and compliance. We support medical devices, in vitro diagnostics (IVDs) and laboratory instruments. We offer design traceability, controlled documentation, and integrated manufacturing under a single project team.
Let's Design Better, Together
Let's Design Better, Together
We are eager to discuss your specific project requirements and explore how our services can help bring your medical innovations to life. Get in touch with us today, and let's collaborate to make a meaningful impact on healthcare, together.
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