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.
Our experience developing software to the IEC 62304 standard and FDA requirements 21 CFR Part 11, 21 CFR Part 820, and CE requirements, means we know what it takes to support the development of compliant medical device products. As we work with a number of US-based companies, we’ve incorporated the most up-to-date TIR45 recommendations into our work processes to aid in verification and validation practices.
Developing to IEC 62304, we have the knowledge to work on medical device projects in class A, B and C categories. 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.