I first worked with Hardian Health as a freelancer, then joined as a director in 2024, when they acquired the Jira-based QMS and design control tool I’d built. I was there until 2026.
The role leant heavily towards regulatory consulting, since the mix of software engineering and regulatory experience was what our clients most often needed. I worked on the more technical side of client submissions across UKCA, CE and FDA: software lifecycles and IEC 62304, requirements, risk and cyber security files.
Alongside the consulting, I built tools for the team and its clients: the Atlassian setup our consulting work moved onto, command line tools for software medical device engineers, and HaRI, a medical device regulatory search platform.