Practical perspectives on medical device regulation — from classification and strategy to certification, compliance, and beyond. Written for founders, technical leads, and teams navigating the regulatory journey.
Early regulatory decisions define the entire certification pathway. In this presentation I explain why Intended Use and classification mistakes can lead to delays, rework, and significant regulatory costs.
We are currently preparing a series of practical articles on medical device regulation — covering topics from EU MDR classification and UKCA requirements to regulatory strategy for SaMD and digital health products.
Check back soon, or get in touch directly if you have a specific regulatory question you'd like us to address.
Get in touchOur blog will focus on practical, actionable regulatory guidance — the kind that helps MedTech founders make better decisions at every stage of the journey.
A practical guide to applying the EU MDR classification rules to software-based products, including common pitfalls and how to build a defensible position.
Why early regulatory thinking saves significant time and money — and what a sound regulatory strategy looks like for an early-stage MedTech company.
An overview of UKCA requirements for medical devices, how they differ from CE marking under EU MDR, and what this means for companies targeting the UK market.
A clear breakdown of the core components of a technical file under EU MDR, and the documentation errors that most frequently cause delays during conformity assessment.
The foundational regulatory questions that shape product development, investment readiness, and market entry — and why getting them right at the start matters.
A practical overview of post-market surveillance obligations for medical device manufacturers under EU MDR — including what documentation is required and when.