EU MDR now has four definitions of well-established technology (WET). How Articles 18, 52 and 61 diverged, what changed in 2026, and what the EU proposes next.

A practical guide to electronic instructions for use (eIFU) for EU medical devices: expanded 2025 scope, the rules under Reg (EU) 2021/2226, and how to comply.

Technical debt — a concept borrowed from software development — applies with equal force to medtech product certification, where deferred decisions and cut corners accumulate into a hidden drag on resource and commercial opportunity. Most senior leaders don't see the cost until a crisis forces the issue; the argument here is for making it visible, measurable, and planned for before that point arrives.

Why regulatory affairs needs a seat at the board table.

Why management style sets organisational risk tolerance, and how this impacts patient safety.

How leadership influences organisational culture, and why this is a critical part of putting quality first.

Regulatory affairs quietly generates competitive intelligence that most medtech businesses never use commercially.

I argue in favour of Edmonson’s psychological safety framework, in building high performing teams.

Why medtech occupies a uniquely challenging space in this triangular paradigm.