⚠️ REGULATORY UPDATE NOTICE

Important: this course was developed under the previous Quality System Regulation (QSR). As of February 2, 2026, the FDA's amended Quality Management System Regulation (QMSR) is now in effect under 21 CFR Part 820.

What changed: the QMSR incorporates ISO 13485:2016 by reference and includes additional FDA-specific requirements.

What this means for you right now: while the core quality management principles in this course remain valid, specific regulatory references, terminology, and certain requirements may differ under the QMSR (more details coming soon).

Action required: always verify current regulatory requirements at www.fda.gov before implementation in your organization.

Please note: this course is scheduled for update to align with QMSR requirements in the near future. Additional information will be provided soon.

Introduction to this course: 

This course explores the structure, key concepts, and requirements of medical device QMS as per ISO 13485:2016.

Who should attend: 

This course is designed for professionals involved in QA/QC, compliance officers, regulatory affairs, manufacturing, and anyone who wishes to gain an understanding of the quality management system for medical devices.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Recall the structure and key components of ISO 13485:2016.

What will I gain: 

Participants will gain a thorough understanding of the structure and key concepts of ISO 13485:2016.

Prerequisites: 

Participants should have a basic understanding of quality management of medical devices.  Familiarity with ISO 9001 and other international standards is beneficial.

Additional information: 

Course duration: 00:36:51

Course code/version (effective date): L-148/v1.0 (07/09/2023)