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Medical Device QMS Overview Training

A must-take class for all medical device RA/QA professionals! This 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 US FDA Quality System Regulation (QSR)21 CFR 820 and the ISO 13485:2016 standard. You’ll come to understand how QSR and ISO 13485 align, how they can be harmonized to maximize efficiency, and where there are opportunities to go beyond the minimum requirements to optimize performance.

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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 (CEU)

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
GRF VIRTUAL DELIVERY (Eastern Time) 16 Oct 2023 20 Oct 2023 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
GRF San Jose, Costa Rica 20 Nov 2023 22 Nov 2023 8:00 a.m. - 5:00 p.m. CR In-Person REGISTER
GRF VIRTUAL DELIVERY (Eastern Time) 04 Dec 2023 08 Dec 2023 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
GRF San Diego, CA 06 Dec 2023 08 Dec 2023 8:00AM - 5:00PM Pacific US Time In-Person 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

At the end of this QMS training course, you’ll understand the basic requirements for FDA’s Quality System Regulation (QSR), ISO 13485:2016, and more. 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 QSR should be implemented at each life-cycle phase. You will address the major QMS subsystems and learn how to prepare for a Notified Body or FDA inspection. This course includes a case study that allows you to apply what you are learning to an example device. 

Course Overview
SkillsLab Class

Quality Management System and Regulatory Overview (Clause 4)

  • Quality management system (QMS) definition and typical components
  • Process-based model for the QMS
  • Basics of US FDA medical device requirements
  • QMS requirements from ISO 13485:2016 (Clauses 0-4) and FDA Quality System Regulation (QSR) 21 CFR 820
Case Study! Identify the Shalls and How to Apply Them

Management Responsibility and Resource Management (Clauses 5 and 6)

  • Requirements from ISO 13485:2016 and FDA 21 CFR 820 for:
    1. Management responsibility
    2. Resource management
Case Study! Identify Resources

Product Realization – Part A (Clauses 7.1 to 7.3)

  • Planning requirements and customer-related process requirements from ISO 13485
  • Design and development requirements: ISO 13485 and 21 CFR 820.30
Case Study! Identify Customers and Their Requirements
Case Study! Connect User Needs and Design Inputs

Product Realization – Part B (Clauses 7.4 to 7.6)

  • Purchasing requirements: ISO 13485 and 21 CFR 820.50
  • Production and service provision requirements: ISO 13485 and 21 CFR 820 (multiple subsections)
  • Control of monitoring and measuring equipment requirements: ISO 13485 and 21 CFR 820.72
Exercise! Assess Purchasing Process Linkages
Case Study! Define Successful Production and Service Provision

Measurement, Analysis and Improvement (Clause 8)

  • ISO 13485 and 21 CFR 820 (multiple subsections) requirements for:
    1. Feedback, complaint handling, reporting to regulatory authorities
    2. Internal audits
    3. Monitoring and measurement of processes and product; control of nonconforming product
    4. Analysis of data; improvement
    5. Corrective and Preventive Action (CAPA)
Exercise! Complaint or Not?
Case Study! Corrections, Corrective Action, and Preventive Action

Global Quality Management Systems and Audit Preparation

  • Common elements found in global QMS requirements
  • 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
SkillsLab

Describe the objectives of a QMS.

Identify the common elements found in global QMS requirements. 

Identify the requirements of ISO 13485:2016 and FDA’s QSR. 

Apply the requirements of ISO 13485:2016 and FDA’s QSR.

Describe the basics of QMS audits and inspections. 

Who Should Attend

Who Should Attend

This is a fundamental course for people working within the medical device industry, including at medical device manufacturers and their suppliers. It is recommended for personnel engaged in the development, manufacturing, or postproduction activities of medical devices working in quality, regulatory, technical, production, and management roles.

  • Engineering Managers
  • RA/QA Managers
  • Executives New to Devices
  • Research & Development
  • Compliance and Legal 
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