REGULATORY AFFAIRS · MANAGEMENT · TRAININGRegulatory affairs isn’t an overhead. It’s your key to market entry.
A new procedure, a submission, succinct training, or a whole staffing model - we’ve got it covered.
We can offer targeted solutions, additional resource, ad-hoc advice or full strategic solutions across three complementary segments.
Strategy, technical files and submissions, market entry, MDR and IVDR transition, eIFU implementation, mock audits and notified body resource.
Procedures, staffing models and organisational design for quality and regulatory functions that need to scale.
Succinct, targeted training for teams that need to understand regulation, quality, and other medical device topics.
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.
How leadership influences organisational culture, and why this is a critical part of putting quality first.
I argue in favour of Edmonson’s psychological safety framework, in building high performing teams.
