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AI-basedmedicalclinical

Bluefruit Software’s UK-based embedded specialists work with innovative clients worldwide. Our team includes software engineers, testers, UX, compliance and quality specialists. Bluefruit believes excellent embedded software happens through investing in people and processes and a dedication to quality. We aim to meet your organisation’s needs across hardware design, software, and high-level technical consulting. Scientific Instruments and Lab Equipment Software: Precise and robust Embedded software and firmware development From super-resolution microscopy to automated workflows: laboratories everywhere are undergoing a digital revolution. Meeting this change, scientific instruments and lab equipment product teams with products going into life sciences, clinical diagnostics and research fields need compliance and precision focused embedded software developers. Medical devices and equipment: compliance-ready medical device software development Bluefruit Software has been the medical device software development partner across multiple medtech products. Our teams provide compliant, innovative software development and testing to ensure our clients get to market with safe, high-quality products. development Our teams work to IEC 62304 across US and EU markets, aligning to ISO 13485. Depending on your product needs, we can meet FDA quality regulations, together with MDD and IVDD directives and support transitions to MDR and IVDR. In 2021, we began working on our first MDR project. And due to working to the demands of the FDA’s regulations for medical devices, we find ourselves well placed to help teams looking to develop products to IVDR.