evolving Medtech and compliance
We work with innovators. The curious. The compliance-savvy.
Changing lives for the better takes attention to detail and a learning-focused attitude. At Bluefruit, our software teams have experience providing embedded software development for medical devices. 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.
Developing to IEC 62304, Bluefruit Software work with clients with medical device products which have a safety classification of Class A and B. We support our clients to meet the evolving EU Medical Devices 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.
We work alongside a range of clients within medical, eHealth and pharmaceutical spaces. Currently, we have two projects within the class A category and two that are class B, working in compliance with IEC 62304.
We realise working with medical devices isn’t just about compliance. With a strong desire to explore and innovate, our team enjoy working on 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.
From recent project experience, we’ve increased our knowledge around applying image recognition to diagnostic devices, linking medical devices up with the NHS spine and working on other connectivity and security requirements. As embedded experts, we are also well versed in challenges around low power consumption or limited processing space.
Bluefruit Software’s quality-focused approach to embedded software development has helped our customers to develop award-winning medical devices that are ready for today and tomorrow.
Whether you’re developing a new medical device for patients or working to enhance lives through new bionic prosthetics, and everything in between—Bluefruit has a team of software engineers and testers for you.
Bluefruit is proud to work with Clinical Design on the world’s only closed system for digital point-of-care urine testing. Their product has already won a Red Dot Design Award and will be launching on to the market soon.
Speak with Bluefruit today!
Looking for quality driven embedded software developers? You've found them.
We are happy to speak about projects of all sizes, from initial consulting to long term partnerships. Please give us a call or drop us an email and we will set up a time to learn more about your requirements and how we can help.