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QMS Training for Medical Devices: ISO 13485:2016 and FDA QMSR

This course equips you with the knowledge to navigate quality management systems (QMS) for medical devices.  Whether you're new to the field or seeking a refresher, it provides a strong foundation in the QMS processes outlined in ISO 13485:2016. We'll delve into how these processes align with the requirements of the US FDA's Quality Management System Regulation (QMSR), ensuring your medical device development and manufacturing meet the most up-to-date quality standards.

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Brief Overview of This Medical Device QMS Training Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

2.4

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** 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 Medical Device Quality Management System Training Classes

SkillsLab $2495

SkillsLab $2495

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
QMF VIRTUAL DELIVERY (Eastern time - PM) 22 Sep 2025 26 Sep 2025 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
QMF VIRTUAL DELIVERY (Eastern time - PM) 08 Dec 2025 12 Dec 2025 1:00PM - 5:00PM 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 Intensive Medical Device QMS Course

This interactive course will introduce you to the quality management system (QMS) requirements for medical devices. Designed for those who are new to the medical device field as well as experienced practitioners looking to refresh their knowledge, this course provides a solid foundation in the QMS requirements found in the ISO 13485:2016 standard and the US FDA Quality Management System Regulation (QMSR). Through engaging classroom discussions, workshops, and activities, you will follow a product’s life cycle to explore how different elements of ISO 13485 and FDA’s QMSR should be implemented at each life-cycle phase. You will address the major QMS subsystems and learn the basics for a QMS third-party audit or FDA inspection.  

 

Course Overview
SkillsLab Class

Quality Management System and Medical Device Basics 

  • Quality management system (QMS) definition and typical components
  • Basics of medical device requirements: US FDA
 

Quality Management System Requirements

  • ISO 13485:2016 Clauses 0-3
  • Process-based model for the QMS
  • QMS-related requirements from ISO 13485:2016 (Clause 4)
  • FDA QMSR 820.7 Incorporation by reference, 820.10 Requirements for QMS, 820.35 Control of records
Exercise! Map a Process

Case Study! Identify the "Shalls" and How to Apply Them

Management Responsibility and Resource Management

  • Management responsibility and resource management requirements from ISO 13485:2016 (Clauses 5-6)
    • Comparison wtih FDA QMSR
Case Study! Identify Resources

Product Realization – Part A

  • Planning-related requirements from ISO 13485:2016 (Clause 7.1)
    • Comparison with FDA QMSR
  • Customer-related requirements from ISO 13485:2016 (Clause 7.2)
    • Comparison with FDA QMSR
  • Design and development requirements from ISO 13485:2016 (Clause 7.3)
    • Comparison with FDA QMSR
Case Study! Identify Customers and Their Requirements
Case Study! Connect User Needs and Design Inputs

Product Realization – Part B

  • Purchasing requirements from ISO 13485:2016 (Clause 7.4)
    • Comparison with FDA QMSR
  • Production and service provision requirements from ISO 13485:2016 (Clause 7.5)
    • Comparison with FDA QMSR
  • Control of monitoring and measuring equipment requirements from ISO 13485:2016 (Clause 7.6)
    • Comparison with FDA QMSR
Exercise! Assess Purchasing Process Linkages
Case Study! Define Successful Production and Service Provision

Measurement, Analysis and Improvement

  • Feedback, complaint handling, reporting to regulatory authorities requirements from ISO 13485:2016 (Clauses 8.2.1-8.2.3)
    • Comparison with FDA QMSR
  • Requirements for internal audits; monitoring and measurement of processes and product; control of nonconforming product; analysis of data; improvement; corrective and preventive action (CAPA) from ISO 13485:2016 (Clauses 8.2.4-8.5)
    • Comparison with FDA QMSR
Exercise! Complaint or Not?
Case Study! Corrections, Corrective Action, and Preventive Action

Global Quality Management Systems and Audit Preparation

  • Overview of global QMS requirements, including Medical Device Single Audit Program (MDSAP) jurisdictions
  • QMS audit basics
  • FDA inspection basics
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
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Describe the objectives of a QMS

Identify the common elements found in global QMS requirements

Use ISO 13485:2016 as the foundation of the QMS

Compare FDA QMSR to those of ISO 13485:2016

Prepare for QMS audits and inspections

Who Should Attend

Who Should Attend

Recommended for anyone working within the medical device industry, including medical device manufacturers and their suppliers. 

  • Quality professionals
  • Regulatory affairs personnel
  • Technical staff involved in medical device development
  • Production personnel
  • Management personnel overseeing medical device activities
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