Get Ready for Market: A Startup’s Guide to ISO 13485 Compliance
Insights Stage

Get Ready for Market: A Startup’s Guide to ISO 13485 Compliance

Regulation
start-ups
compliance
jeudi, 4 juin 2026
11:30 - 12:00 | Europe/London

Presentation

English
About
This session provides a practical, startup‑oriented guide to building a Quality Management System aligned with ISO 13485 and ready for market access.

You will hear how ISO 13485 supports regulatory requirements, and the expectations during QMS audits. Common audit pitfalls will be highlighted to help startups avoid delays and demonstrate a robust, market‑ready QMS from the outset.
 

Speakers

Ajith John

Global Quality and Accreditation Certification LeadBSI

Michelle Rae

Service Delivery Manager EMEA Medical DevicesBSI