From ISO 9001 to ISO 13485: Navigating the Shift from Automotive to Medical Device Quality Standards

Event Date(s) :
Thursday, Oct 09, 2025
Tags :
Webinar
Jana Osterritter
From ISO 9001 to ISO 13485

Abstract

Moving from automotive to medical devices? It’s more than just changing standards.

Join us for a focused one-hour webinar that explores the critical shift from ISO 9001 to ISO 13485. A transition that demands more than updated documentation. It requires a new mindset, deeper regulatory understanding, and refined quality processes.

What you’ll learn:

  • Key differences between ISO 9001 and ISO 13485
  • Regulatory and quality management implications
  • Common challenges and pitfalls during implementation
  • Practical strategies for a smooth and compliant migration

This session is ideal for quality and regulatory professionals entering or expanding into the medical device industry, especially those with a background in automotive quality systems.

Request the recording