ISO 13485: 2016 Overview

If you’re a medical device manufacturer, distributor, or startup founder, understanding ISO 13485 is not optional; it’s your license to operate.

This session provides a comprehensive understanding of ISO 13485:2016, the international standard for Quality Management Systems in the medical device industry.

You’ll learn:

• The structure and intent behind each clause of ISO 13485.
• The differences between ISO 9001 and ISO 13485, and why general QMS systems fail in the medtech industry.
• How Design Control, Risk Management, and Post-Market Surveillance fit into your QMS.
• Documentation hierarchy – how to structure your SOPs, records, and master lists.
• Common audit findings and how to avoid them.

Value to your company:

This overview will align your entire leadership and QA team with the language of compliance, enabling you to talk to auditors, consultants, and regulators with absolute confidence.

You’ll leave knowing exactly what it takes to build an ISO 13485-compliant foundation.