evolving technology and compliance
You work with innovators. The curious. The compliance-savvy.
Changing lives for the better takes attention to detail and a learning-focused attitude. Our experience developing 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 develop compliant medical device products that are market ready. We’ve also incorporated TIR45 recommendations into our work processes to aid in verification and validation practices.
Developing to IEC 62304, we have the knowledge to work on MedTech 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.
This all means you can bring advancements to treatments, diagnosis, and support that will change people’s lives. The use of AI, robotic implants, diagnositic devices and more can only happen when you’re supported to meet global standards.
Bluefruit Software’s quality-focused approach to embedded software development has helped our customers to develop award-winning med tech that’s ready for today and tomorrow.
Whether you’re developing a new testing 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.
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.