Webinar | Launching a medical device? Here’s how to build your first ISO 13485 QMS скачать в хорошем качестве

Webinar | Launching a medical device? Here’s how to build your first ISO 13485 QMS

Jump to section: 00:00 Webinar intro & objectives 09:24 Key Steps to Build an Effective eQMS 10:05 Step 0 - Sharpen the axe 10:54 Step 1 - Structure your document architecture 12:31 Step 2 - Master your processes and procedures 13:56 Step 3 - Manage risks - but don't mix them up! 15:41 Step 4 - A QMS aligned with ISO 13485 & MDR 17:11 Why TraceX? 19:15 Q&A Launching a medical device? Don’t let documentation chaos slow you down. In this session, Guillaume Valenzuela (CSDmed) — QARA consultant and ISO 13485 Lead Auditor — shares a clear, practical method to build your first Quality Management System (QMS), aligned with ISO 13485, MDR, and FDA requirements. What you’ll learn: • Common QMS mistakes to avoid • Key steps to structure your documentation and processes • How to integrate risk management and lifecycle thinking from day one • Why TraceX is a great free tool to start your eQMS journey Perfect for medtech startups, consultants, and growing teams getting audit-ready. Get the clarity you need to build a QMS that works — and scales. TraceX | www.tracex.co/ GitHub | github.com/hcengineering Twitter/X | @TraceXeQMS LinkedIn | @tracex-company