We are embedded software experts for medical devices.
Compliance-savvy embedded software development and testing
Bluefruit Software has been delivering quality-critical software for more than 20 years and is home to over 72 UK based embedded software engineers and testers. Our medical experience includes working on diagnostic devices, health monitors, medical equipment, medical instruments and laboratory equipment.
Why Bluefruit Software?
- IEC 62304 experience across seven medical products
- Familiarity in software development and testing for Class A, B and C
- Supporting clients to meet EU Medical Devices legislation and FDA requirements
- Aligned to ISO 13485, 21 CFR Part 820 and Part 11
- Lean-Agile practitioners guided by TIR45
- Automated test development for continuous feedback loops
- Validation and Verification
- 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
Our experience also includes precision equipment for biopharmaceutical, scientific and industrial use, including lab water delivery systems, gas chromatographs and peristaltic pumps.
Get in touch today and find out how we can help ensure a high-quality software outcome for your medtech project.
“I regard Bluefruit as an extension of the internal development team.”
Lee Underwood, ELGA LabWater
Interested in an Estimate?
Set up a call to discuss your requirements.