We work with clients to provide quality software for world-leading medical devices, reliable laboratory equipment, and wearable tech for the healthcare industry.
Bluefruit understand the unique challenges and risks that come with working within the laboratory equipment and medical device spaces. From blood and urine point of care systems to precision water dispensers; Bluefruit’s reputation for delivering software solutions in quality-critical environments has resulted in numerous medical device, eHealth, and lab tech projects. Our team of skilled software engineers and test engineers provide a high level of embedded experience, as well as cloud-based solutions for connected devices. We are happy to work across all stages of the product lifecycle, and with our client’s existing software development teams.
How can we help?
Our skills and experience includes the following:
– Embedded software expertise
– Experience writing software for FDA and CE approval complying with IEC 62304 and following TIR45 guidance
– Documentation to meet medical standards; from processes to evidence and validation
– Tool validation
– Lean Agile development approach (using behaviour and test-driven software development) for high-quality, robust, and safe software
– Code quality reports
– Proof of concept projects and R&D collaboration
– Late stage integration support
– Consulting on code to help achieve medical standards approval