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.
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.

