Medical devices and equipment: compliance-ready medical device software development
Reliable medical device software development
Changing lives for the better takes attention to detail and a learning-focused attitude.
With a quality-driven approach to embedded software development, our teams enjoy working on projects within the medical space. Bluefruit Software has been the medical device software development partner across seven medtech products working to both FDA and IEC standards. Providing quality-focused software development and testing, our medical experience includes working on diagnostic devices, health monitors, medical equipment, medical instruments, and laboratory equipment.
We also have a verification and validation team that can plug into a larger multidisciplinary team and if needed we can work with clients to explore creating a custom automated testing solution.
Why Bluefruit Software?
- Multidisciplinary teams of Embedded Software Engineers, Testers and Quality Analysts
- IEC 62304 experience across seven medical device products
- Familiarity in software development and testing for Class A, B, and C and Class I, II and III
- Supporting clients to meet EU Medical Devices legislation and FDA requirements
- Aligned to ISO 13485, 21 CFR Part 820 and Part 11
- Compliance-focused, Lean-Agile practitioners guided by TIR45
- Automated test development for continuous feedback loops
- Verification and Validation capacity
- Rapid Prototyping for user-centric design
- Quality processes that link seamlessly with client Quality Management Systems
- Work with your existing teams and plug in at any point in your product lifecycle
Developing to IEC 62304 and FDA regulations, Bluefruit Software work with a range of clients within medical, eHealth and pharmaceutical spaces, which all must adhere to stringent safety classifications. We support our clients to meet evolving EU legislation and FDA requirements. Our quality management processes are aligned to ISO 13485, 21 CFR Part 820 and Part 11, and as practitioners of Lean-Agile, we are heavily influenced by the guidance of TIR45 in tailoring our software development practices to individual client needs.
Some of our most recent project experience, has included applying image recognition to diagnostic devices, linking medical devices up with EMIS and working on other connectivity and cyber security requirements. As embedded experts, we are also well versed in challenges around product reliability and product evolution on existing medical devices or equipment.
Bluefruit Software brings quality and innovation primed know how to medical devices
- Quality focused Lean-Agile development processes: Test-first approach to software that is harmonised with TIR45, adhering to documentation and quality management requirements. For Bluefruit, we believe it’s important that following compliance adds value rather than becoming a burden.
- Artificial Intelligence: Expertise in machine vision and machine learning for clients and internal neural network R&D, sees the team ready for AI in embedded projects. Further exploration in medical compliance in this space is a key part of our internal R&D strategy.
- Internet of Things (IoT) and connectivity solutions: Extensive IoT and connectivity experience, including Wi-Fi, Bluetooth, RS232/RS485, Thread, cloud, cellular, edge computing, Embedded Ethernet, RFID and more.
- Cyber security: Risk aware cyber security experts ready to assess software with an eye to global regulatory standards and evolving threats.
- Reimagining user interfaces: With Embedded Linux and Qt, led by latest UX thinking, and UI with automated “selenium style” acceptance testing/BDD.
- Precise dosing: Development knowhow to bring precision to systems involving fluids and other materials.
- Real-time: From real-time event handling to data collection, our engineers have experience in sensors, controls, alerts, and data capture.
- Software that’s easy to update: Past client projects have included custom secure bootloaders, USB based updates, and cloud based updates.
Support for pioneering R&D teams
We realise working with medical devices isn’t just about compliance. With a strong desire to explore and innovate, our teams enjoy working on healthcare projects that allow us to incorporate cutting-edge technology. From AI-driven diagnostics to robotic limbs: we are excited about the opportunity to work with product teams on medical devices that will make a difference.
Case studies and medtech development insights
❝ With years of working together, we regard Bluefruit as a valued extension of our internal product development team. ❞
❝ 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. ❞
❝ A 'can do' approach shines through on each project, with customer satisfaction very much at the top of the list. ❞
❝ 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. ❞
Need embedded software engineers and testers for your medical device?
Our multidisciplinary teams can work alongside existing in-house teams or be your full software and testing provider for medical device development. We can even help you assess any skills gaps and propose a team that fits with your in-house teams. Whether the product requires EU or FDA approval, out teams have the skills and experience your project needs.