Medical devices and equipment: compliance-ready medical device software development
Reliable 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.
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.
On this page:
- Bluefruit Software aligns with ISO 13485
- Why Bluefruit Software?
- Medtech experience
- Bluefruit Software delivers quality and innovation
- Support for pioneering R&D teams
(You can also find on this page: case studies and links to key medical software development insights.)
Our teams enjoy working on projects within the medical space with a quality-driven approach to embedded software development.
We’ve worked on medtech diagnostic devices, health monitors, medical equipment, medical instruments, and laboratory equipment, providing quality-focused software development and testing.
We also have a verification and validation team that can plug into a larger multidisciplinary team. If needed, we can work with clients to explore creating a custom automated testing solution.
Bluefruit Software aligns with ISO 13485
Bluefruit Software is aligned with ISO 13485 but does not have ISO 13485 certification.
We’ve chosen to do this because we believe it will not benefit the Lean-Agile practices that we use in medical embedded software development.
For our medical device clients, we ensure our processes match up with what ISO 13485 asks so that auditing software is simple.
- What this means for your project: You benefit from a team able to use your QMS rather than their own.
- Flexibility in development strategies to align with your QMS.
- Access to a team with existing experience of working to IEC 62304.
- Technical and project practices that create clear lines of project history.
- Options for living documentation for your product’s software development.
Should you need evidence of our capabilities of working to IEC 62304, please read through our medical device project case studies. If you would like to see more evidence, please get in touch.
Why Bluefruit Software?
- Multidisciplinary teams of Embedded Software Engineers, Testers and Quality Analysts.
- IEC 62304 experience across eight medical device products.
- Familiarity in software development and testing for Class A, B, and C in devices of all risk classes.
- Supporting clients to meet EU Medical Devices legislation and FDA requirements.
- Aligned to ISO 13485 and 21 CFR 820 and ability to comply with 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, Bluefruit Software works with a range of clients within medical, eHealth, and pharmaceutical spaces, all of which must adhere to stringent safety classifications. We support our clients to meet evolving EU legislation and FDA requirements. Our quality management processes align with ISO 13485, 21 CFR 820 and Part 11. As practitioners of Lean-Agile, we are heavily influenced by the guidance of TIR45 in tailoring our software development practices to individual client needs.
Our most recent project experience has included applying image recognition to diagnostic devices, linking medical devices to 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, equipment and medical software development services.
Bluefruit Software delivers quality and innovation primed know how to medical devices
- Quality focused Lean-Agile development processes: Test-first approach to software harmonised with TIR45, adhering to documentation and quality management requirements. For Bluefruit, we believe it’s vital 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 crucial 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 know-how 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.
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Support for pioneering R&D teams
We realise that 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.
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.
Case studies for medical device software development
Diagnostic device case study: client gained FDA approval through effective Verification and Validation
Our client is a large international company working to disrupt the current healthcare testing process with a new point of care diagnostic testing device. Their product is aimed at both the European and US markets. Here’s how Bluefruit Software worked with an existing project team, including several outsourced partners, to support development of a new medical device.
Medtech software 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.