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Transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) - DaySmart Series

Get up to speed in one day! Give yourself the gift of focused time to understand FDA’s QMSR and jumpstart your organization’s transition to the updated requirements. Join this instructor-led interactive session that includes an examination of the QMSR requirements and an opportunity to assess their impact on your existing quality management system (QMS) processes.

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Brief Overview of This FDA QMSR Training Class

DaySmart Class ?

Class Content

Foundational Overview

Class Duration

6 Hours (One Day)

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person*

Certification of Completion

Yes

Continuing Education Units (CEUs)

0.6

* Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Classes on the FDA Quality Management System Regulation

DaySmart $995

DaySmart $995

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
FDD VIRTUAL DELIVERY (Eastern Time) 02 Jul 2025 02 Jul 2025 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
FDD VIRTUAL DELIVERY (Eastern Time) 16 Oct 2025 16 Oct 2025 10:30AM - 5:30PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This FDA QMSR Training Course

Our DaySmart option provides a foundational overview of the FDA's new Quality Management System Regulation (QMSR). Using a hands-on learning approach, you'll leave the class knowing what it takes to comply with this new regulation.

Note: This course is intended for learners who already understand the requirements of FDA’s existing Quality System Regulation (QSR) and/or ISO 13485:2016. This course is not designed for learners new to medical device quality system requirements. For novices in this area, please ask us to recommend a more appropriate course.

Course Overview
DaySmart Class

FDA QMSR Overview

  • FDA QMSR myths and misconceptions
  • Overview of QMSR: Purpose, structure
  • Conforming edits to Part 4
  • High-level overview of differences between FDA QSR, ISO 13485:2016, and FDA QMSR
Activity! Start an Impact Map

FDA QMSR and ISO 13485:2016 Clauses 0-6

  • QMSR scope (820.1), definitions (820.3), incorporation by reference (820.7), and requirements for a QMS (820.10)
  • Differences between ISO 13485:2016 clauses 0-6, QSR, and QMSR
  • QMSR impact on quality management system, management responsibility, and resource management processes
Activity! Assess QMSR Impact on Your Organization's Processes

FDA QMSR and ISO 13485:2016 Clause 7

  • Differences between ISO 13485:2016 clause 7, QSR, and QMSR
  • QMSR impact on product realization processes
Activity! Assess QMSR Impact on Your Organization's Processes, Cont.

FDA QMSR and ISO 13485:2016 Clause 8

  • Differences between ISO 13485:2016 clause 8, QSR, and QMSR
  • QMSR impact on measurement, analysis, and improvement processes
  • QMSR 820.35 requirements for control of records
  • QMSR 820.45 requirements for device labeling and packaging controls
Activity! Assess QMSR Impact on Your Organization's Processes, Cont.

FDA QMSR Implementation

  • QMSR implementation steps and best practices
Activity! Identify Next Steps for Your Organization
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
DaySmart

Explain how FDA's QSR and the QMSR are different.

Identify FDA QMSR requirements that are additional to ISO 13485:2016.

Determine the impact of FDA's QMSR requirements on existing quality management system processes.

Prepare for the transition to FDA QMSR.

Who Should Attend

Who Should Attend

Prerequisite: All attendees must be familiar with the requirements in FDA's current Quality System Regulation 21 CFR Part 820 and/or ISO 13485:2016.

This course is recommended for anyone in the organization contributing to meet FDA medical device regulatory requirements. This includes personnel engaged in the development, manufacturing, or postproduction activities of medical devices working in quality, regulatory, technical, production, and management roles. 

  • Quality Managers
  • Regulatory Professionals
  • Operations Managers
  • Internal Auditors
  • Compliance and Legal 
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