Looking for embedded software experts for medical devices and equipment who understand compliance?
Compliance-savvy embedded software development and testing for Medical Equipment and Medical Devices
Bluefruit Software has been delivering quality-critical software for more than 25 years and is home to over 65 UK based embedded software engineers, software testers, quality and compliance specialists.
With extensive experience working in regulated sectors, we can help at all points of the product lifecycle, from new projects to legacy software. If you have existing internal development teams and processes, our teams can integrate with them.
We understand the challenges faced by companies working on medical software projects that need to meet FDA or MDR, IEC 62304 and IEC 61508 requirements. Guided by TIR45, our expert teams can work closely with you to help compliance add value to your software project alongside the delivery of high quality and user-centred embedded software.
We have worked with classes A to C on previous medical device software and SamD projects, using IEC 62304, 61508 and FDA requirements 21 CFR Part 11, 21 CFR Part 820, and CE requirements. We can also work with ISO 13485, ISO 14971, and IEC 62366.
Our medical software development and testing experience includes work on:
- Medical Devices & Equipment
- Medical Instruments
- Laboratory Equipment
- Scientific Instruments
- Diagnostic Devices
- Health Monitors
In addition to our value-driven Lean-Agile software development processes, we have a robust quality management process built to align with ISO 13485. We know that every project is different and we would be happy to discuss how we would approach compliance for your project.
Our experience also includes precision equipment for biopharmaceutical, scientific and industrial use, including lab water delivery systems, gas chromatographs, and peristaltic pumps.
Why Bluefruit Software?
- Multidisciplinary teams of Embedded Software Engineers, Testers and Quality Analysts.
- IEC 62304 and IEC 61508 experience across multiple medical device products.
- Familiarity in software development and testing for Class A, B, and C in devices of all risk classes.
- Supporting clients to meet EU Medical Devices legislation and FDA requirements.
- Aligned to ISO 13485 and 21 CFR 820 and ability to comply with Part 11.
- Compliance-focused, Lean-Agile practitioners guided by TIR45.
- Automated test development for continuous feedback loops.
- Verification and Validation capacity.
- Rapid Prototyping for user-centric design.
- Quality processes that link seamlessly with client Quality Management Systems.
- Work with your existing teams and plug in at any point in your product lifecycle.
Read more in our case studies
Resources:
Current and previous clients
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