In this session, I will provide an overview of the route to market for medical device manufacturers. I’ll break down the ISO 13485 certification pathway into clear, manageable stages, outlining what manufacturers should expect at each step.

This includes:
Simplifying the ISO 13485 certification process so organisations understand what is required and why it matters.
Exploring the key stages and typical timescales for engagement, from initial readiness assessments through to final certification.
Highlighting common pitfalls and challenges that companies encounter on their journey to certification and market access — and how to avoid them.
By the end of the session, attendees will have a clearer understanding of how to navigate the regulatory landscape efficiently and position their medical devices for successful market entry.