Compliance - Bluefruit Software

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Compliance

From medtech to aerospace

Safety-critical industries, such as medtech and aerospace, need software engineers who are compliance-savvy.

Within the medical and scientific instrument space our team members have experience working to the IEC 62304 standard and FDA requirements 21 CFR Part 11, 21 CFR Part 820, and CE requirements. We’ve also worked to bring in TIR45 into our work processes, helping with verification and validation for Medical Devices. We have worked on both Class A and Class B medical devices and are happy to discuss how we would approach meeting class C requirements. Previous work involving IEC 62304 has involved us writing software for class A and B medtech devices.

Our team is also able to work to ISO 13485, ISO 14971 and IEC 62366.

Outside of medtech, we have also delivered aerospace projects that meet the DO-178B standard.

Bluefruit’s team follows a quality-focused approach to embedded software. Where appropriate, we work to the MISRA C and MISRA C++ standards when working in C and C++.

This ensures that we write software that meets compliance needs for today. And that software that has habitability, scalability and maintainability.