The Wound Brief

The Wound Brief explains wound care medical devices: how they work, how they're regulated, and how they get to market.

I'm Christian Stephenson. I've spent 30 years in medical devices, from start-ups to blue-chip companies, including setting up wound care manufacturing. Each episode takes one topic and makes it clear: device classification under the EU MDR and FDA, claims and evidence, sterility and biocompatibility, scale-up, and market access.

Series:
• Foundations: how wound care products work
• Development Explained: practical development and regulatory topics
• Deep Dives: longer looks at strategy, evidence and access

Education, not regulatory advice. For consultancy, visit Karandash Consulting. https://karandashconsulting.com/