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. For information on this, please see our page detailing our capabilities in software development for medical devices.
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.
Find out if your medical device software is IEC 62304 ready
Are you wondering how well your device software holds up against IEC 62304? You can download your copy of The essential IEC 62304 checklist today.
The essential IEC 62304 checklist will help you:
- Understand critical parts of the standard from a business perspective.
- See the early signs of whether your medical device software is audit-ready or not.
- Discover key opportunities working to IEC 62304 presents for your business.
Download your checklist and answer:
❝ Paul and his team have worked with us on a number of projects and bring an extra dimension to software product development in terms of their commitment and technical expertise. ❞
❝ A 'can do' approach shines through on each project, with customer satisfaction very much at the top of the list. ❞
❝ With years of working together, we regard Bluefruit as a valued extension of our internal product development team. ❞
❝ Bluefruit provide a professional, innovative and technical team in a very friendly environment. They display a culture of continuous improvement in everything they do for us, this and their positive approach to every challenge makes them a great partner to work with. ❞