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Groundbreaking, digital point-of-care producer gets the outcomes they need

For three years, our client has worked closely with Bluefruit Software to develop and take to market a world first point-of-care testing system. The product has been widely recognised for its technical innovation and design.

Project Overview:

Initially, we were asked to provide consultation on connectivity and integration so that the unit could interface with healthcare platforms like EMIS. The consultation led to our team developing Windows software for the product aimed at healthcare practitioners.

Impressed with our solution, our client asked us to start development of the embedded firmware for their testing unit. Automated diagnostics was a critical feature. We created imaging software, that used machine vision, enabling the camera within the device to provide rapid and accurate automated diagnosis.

Using Lean-Agile practices ensured regular releases, clearer requirements gathering and short feedback loops. This coordination enabled our client to closely collaborate with us on high-quality software.

Our team is currently supporting the client to achieve CE approval and later worldwide regulatory approvals.

Challenges faced by Bluefruit Software:

  • Aligning project methodologies.
  • Writing software for an existing hardware platform.
  • Medical analysis via image capture and colour recognition with an unpredictable source.

What our client gained:

  • IEC 62304 experienced developers.
  • Lean-Agile embedded software experts with a focus on quality.
  • Software that implemented effective machine vision.
  • A working iteration of software every two weeks.
  • Regular technology demos to support continued investment.
  • Proof of concepts to prove product capabilities.
  • Short feedback loops between development, testing and releases.
  • A responsive development team that enabled the project to pivot on demand.

Find out if your medical device software is IEC 62304 ready

Are you wondering how well your device software holds up against IEC 62304? You can download your copy of The essential IEC 62304 checklist today.

The essential IEC 62304 checklist will help you:

  • Understand critical parts of the standard from a business perspective.
  • See the early signs of whether your medical device software is audit-ready or not.
  • Discover key opportunities working to IEC 62304 presents for your business.
Download your checklist

❝ Paul and his team have worked with us on a number of projects and bring an extra dimension to software product development in terms of their commitment and technical expertise. ❞

Richard O’Neill, AGC Instruments

❝ With years of working together, we regard Bluefruit as a valued extension of our internal product development team. ❞

Lee Underwood, ELGA LabWater

❝ Bluefruit provide a professional, innovative and technical team in a very friendly environment. They display a culture of continuous improvement in everything they do for us, this and their positive approach to every challenge makes them a great partner to work with. ❞