Bluefruit Software

Name: Bluefruit Software
Address: Gateway Business Centre, Barncoose Gateway Park, Redruth, TR153RQ, GB
Telephone: 03335 777 111
Price range: ££

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Bluefruit Software

Bluefruit Software’s UK based embedded software specialists work with innovative clients worldwide.

Bluefruit Software’s UK-based embedded specialists work with innovative clients worldwide. Our team of over 85 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 work closely with clients operating in safety-critical spaces. We aim to meet your

organisation’s needs across hardware design, software, and high-level technical consulting. Industries we work in:

• Medical Devices & Equipment
• Aerospace & Space
• Scientific Instruments & Laboratory Equipment
• Industrial Systems
• Automotive
• Agritech

01/06/2026

From 2 August 2026, AI systems deemed high-risk under the new EU AI Act must comply with its strict provisions. This includes AI-based components in:
- Critical infrastructure, such as transport, including autonomous vehicles and passenger safety monitoring systems

- Medical devices, such as robotic surgeon tools and therapeutic aids that help accelerate recovery through adaptive decision making
- Civilian-use defence and security systems, such as public biometric detection and threat detection tools
- Aerospace devices, such as flight control systems, aircraft health monitoring platforms, and predictive maintenance tools

If you’ve yet to get to grips with the EU AI Act, time is running short. And with a long list of legal and commercial penalties, it’s essential that you understand what the act covers, what’s exempt, and what applies to any devices and software that you are selling into the EU.

Bluefruit's essential guide to the act explains what the act is, why it exists, what it means for your AI systems, how it operates alongside existing standards (such as IEC 62304, DO-178C, and IEC 61508), the risks of non-compliance, and what you need to do to prepare for that looming deadline.

Read the guide, What does the EU AI Act mean for device manufacturers? 👉 https://eu1.hubs.ly/H0vNlFc0

19/05/2026

Bluefruit is heading back to Boston in June, and we’re really excited to be co-hosting a community drinks meetup with our friends at Prodct Studio the evening before the International MedTech Safety Conference (IMSC26) kicks off.

Bluefruit and Prodct share a commitment to building thoughtful, high-quality tech products with meaning and purpose. We think some of the best outcomes come when smart people get together at a place with great food and drink on the fringes of a big conference. So we’re looking forward to bringing the community together to share ideas, make new connections, and celebrate the work happening across healthcare innovation.

If you’re heading to the conference (or even if you’re not), we’d love you to join us at the Mighty Squirrel Taproom and Kitchen in Watertown on Monday, June 1 2026, at 6 - 9 PM. Get all the details and let us know you’re coming along: https://eu1.hubs.ly/H0vr1c90

14/05/2026

Next month, on the 9 and 10 June 2026, James and Alex from Bluefruit will be riding the Bluefruit tour bus to Düsseldorf, Germany for The European Medical Device Summit.

Bluefruit is sponsoring the summit, we’ll have a stand there, and we will be having one-to-one meetings with delegates, talking all things software for medical, pharma, and lab and scientific. If you’re going to be there, please drop James, Alex, or Bluefruit HQ a message to let us know so we can book a time and place to catch up.

More information on the European Medical Device Summit 2026: https://eu1.hubs.ly/H0vkLbZ0

30/04/2026

When the embedded software in your product uses third-party software libraries (a lot of it does), you are effectively renting your software.

For highly regulated embedded projects (for example, medical or other safety-critical systems), building and owning your own software can be a smart alternative to renting it. But it can be difficult to convince those in charge of the budget who don’t understand software that a capital expenditure (CapEx) model makes financial sense.

Our post unpacks the core differences between the OpEx and CapEx financial models and shows you how to build a watertight business case for software ownership. And our software ownership calculator does the maths on OpEx versus CapEx models of software ownership for your product, helping you win support across your organisation. Links below in comments 👇

28/04/2026

Product embedded software development can quickly become overwhelming. What starts as a simple project may grow into a complex tangle of hardware revisions, evolving feature sets, and toolchain updates. Teams end up continually revising and building on their code. But with every update, there’s a risk of unintentionally breaking behaviour that previously worked as expected.

That’s why regression testing—the practice of re-running tests after code changes to verify that the software still performs as intended—is essential. But we often see that it’s a practice that’s delayed or dismissed altogether.

Read Bluefruit’s guide to find out what regression testing is, why it’s so important, and how to get the best from your regression testing strategy: https://eu1.hubs.ly/H0tTLmf0

17/04/2026

From 28 May 2026, key parts of the European Database on Medical Devices (EUDAMED) will become mandatory under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

If you manufacture medical devices and your products are on the market within the EU and/or Northern Ireland supply chain, you must register with EUDAMED. The risks of non-compliance include delayed or blocked access to the market and increased regulatory scrutiny. And the rules don't apply only to new devices. Any legacy devices first placed on the EU market before May 2026 must be registered in EUDAMED by November 2026.

Bluefruit's in-depth guide to EUDAMED explains what the regulations are, helps you to understand what parts of the regulations apply to you and when, and sets out what you need to do right now to prepare: https://eu1.hubs.ly/H0tBNWM0

13/04/2026

End-of-line (EOL) systems are the final safeguard in all manufacturing processes. Whatever your product, EOL checks play a vital role in ensuring quality, reliability, safety, and accuracy. Get it wrong, and you put customer safety and satisfaction, and your revenue and your reputation at risk.

Despite all this, we know that many manufacturers continue to rely on outdated EOL software, often developed years ago by a single engineer (who has often moved on or is happily enjoying their retirement). And yet EOL technology and software are moving forward at pace, with AI transforming how manufacturers approach quality control, efficiency, and predictive maintenance.

Read Bluefruiter Tristan’s in-depth guide to end-of-life systems and software to understand the basics, the risks to your business of falling behind, and the opportunities of evolution and revolution: https://eu1.hubs.ly/H0tqgT20

25/03/2026

The European Database on Medical Devices (EUDAMED) has taken nearly a decade to land, but its first major compliance milestone is now in sight – and it’s closer than many manufacturers realise. From 28 May 2026, key parts of EUDAMED will become mandatory under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Given multiple delays and many significant changes to the system, there's still a lot of uncertainty around what's required by the regulations. But: be assured that if you market a medical device within the EU and/or Northern Ireland supply chain, you MUST register with EUDAMED.

Read Ben Philpott's guide that cuts through the confusion by explaining what EUDAMED is for, which requirements are becoming mandatory in May, and what your teams need to be doing right now: https://eu1.hubs.ly/H0sXkjW0

18/03/2026

If you can’t prove the embedded software in your safety-related product prevents harm, you risk delayed certification, more scrutinous audits, or even blocked market access. And that would really hurt your bottom line.

IEC 61508 and its functional safety guardrails can help reduce the risk of harm to a tolerable level, even in the presence of environmental interference and human error. But, at over 500 pages, the standard is a dense and highly technical framework that can discourage even the most disciplined software teams. That’s why we've created a functional safety companion guide that translates IEC 61508 into clear, practical, and repeatable actions that make it simpler to apply functional safety principles across the product lifecycle.

Get hold of your copy of The Bluefruit essential IEC 61508 checklist: https://eu1.hubs.ly/H0sKJWs0

16/03/2026

Read about these common software oversights made by medical device execs and how you can tackle them:
- Absent solid test strategy
- Compliance isn’t used to add value
- Zero over-the-air updates
- Not using automated testing
- Using unvalidated tools
- Poor psychological safety
- Code quality isn’t invested in.
👉 https://eu1.hubs.ly/H0sGzZP0

Address

Gateway Business Centre, Barncoose Gateway Park
Redruth
TR153RQ

Telephone

03335 777 111

Website

http://www.bluefruit.co.uk/

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