Fractional software leadership
I stand up and run software functions for medical device and IVD companies. Planning, people, documentation and delivery, built to IEC 62304 and ISO 13485 and ready for audit.
Tell me about your productWho this is for
First regulated product
The device is real and the software now has to meet IEC 62304 before a notified body sees it. I set up the lifecycle, the documentation and the team so development starts compliant instead of getting remediated later.
Audit gaps
Certification or surveillance is booked and the evidence isn't where it should be. I run the gap analysis, do the remediation and sit in the audit with you.
Outsourced build
Your software or firmware is built externally, and IEC 62304 makes you responsible for it regardless. I hold the supplier to the standard from your side of the table.
Sectors I've delivered in
A software director on the days you need one, owning the plan, the team and the board pack.
Gap analysis through to a complete, audit-ready software file.
Technical ownership of outsourced software and firmware, on your side of the table.
Current engagement
Currently Software Director at a Belgian medtech spin-off, building the software function for a Class C in vitro diagnostic.
Fixed scope, fixed price
Two weeks, one product, one codebase. Written report and prioritised remediation plan. £7,500 fixed, plus VAT.