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

Choose from classroom or online delivery.

The must-take foundation course for all medical device RA/QA professionals!

At the end of this medical device 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. You’ll come to understand how QSR and ISO 13485:2016 align with one another, how they can be harmonized to maximize efficiency, and where there are opportunities to go beyond the minimum requirements to optimize performance.

Designed for those who are new to the medical device field as well as experienced practitioners looking to refresh their knowledge, this course will provide you with a solid foundation on which to build a successful career in medical device RA/QA.

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Course Date

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.
Location Start Date Days Cost Public Private
VIRTUAL DELIVERY (Eastern Time) 02/13/2023 5 $2695.00 Add to Cart Contact Us
San Francisco Area, CA 03/06/2023 3 $2695.00 Add to Cart Contact Us
Minneapolis, MN 03/15/2023 3 $2695.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 03/20/2023 5 $2695.00 Add to Cart Contact Us
Chicago, IL 04/17/2023 3 $2695.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 04/24/2023 5 $2695.00 Add to Cart Contact Us
San Jose, Costa Rica 05/17/2023 3 $2695.00 Add to Cart Contact Us
Washington, DC 05/31/2023 3 $2695.00 Add to Cart Contact Us
San Diego, CA 06/21/2023 3 $2695.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 06/26/2023 5 $2695.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 07/24/2023 5 $2695.00 Add to Cart Contact Us
San Francisco Area, CA 07/31/2023 5 $2695.00 Add to Cart Contact Us
Minneapolis, MN 08/14/2023 3 $2695.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 08/21/2023 5 $2695.00 Add to Cart Contact Us
Boston, MA 09/11/2023 3 $2695.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 09/18/2023 5 $2695.00 Add to Cart Contact Us
Chicago, IL 10/09/2023 3 $2695.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 10/16/2023 5 $2695.00 Add to Cart Contact Us
Orlando, FL 11/06/2023 3 $2695.00 Add to Cart Contact Us
San Jose, Costa Rica 11/20/2023 3 $2695.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 12/04/2023 5 $2695.00 Add to Cart Contact Us
San Diego, CA 12/06/2023 3 $2695.00 Add to Cart Contact Us

Course Detail

Objectives

At the end of this course, participants will be able to:

  • Describe the objectives of ISO 13485:2016 and FDA's QSR
  • Identify the requirements of ISO 13485:2016 and FDA's QSR
  • Apply the requirements of ISO 13485:2016 and FDA's QSR
  • Identify the common elements found in global QMS requirements
  • Describe how to plan and prepare for FDA, Notified Body, and MDSAP inspections/audits

Topics

  • FDA QSR background and subpart review compared against ISO 13485 standard clauses
  • Major subsystems: management controls, design controls, production and process controls, and CAPA
  • Application of risk-based approach

Who Should Attend

This course is appropriate for anyone who needs to understand how to meet the requirements of a global medical device quality system, including R&D or engineering managers; management representatives; product, project, and program managers; RA/QA managers/engineers; internal auditors; compliance and legal; and other cross-functional team members. 

Virtual Class Days

  • The virtual version of this class is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Time.
  • Virtual Half-Days

    5
  • In-Person Full-Days

    3
  • CEUs

    2.4

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX is known for our in-person workshops and hands-on activities, and we use an extensive toolbox to foster similar engagement and attention in our virtual classes. Our instructor and students interact in real time via our flexible, online learning platform, resulting in an engaging and real-class environment.

This is an ideal alternative to the typical classroom setting for quality and regulatory professionals who are unable to travel or who just prefer the convenience of attending a class without having to leave their own personal environment.

Virtual Instructor-Led Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

See course dates to find / register for a virtual online session of this course.

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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