Loading ...

Public Training Course Dates & Information:

Course Catalog PDF Download Catalog »
Private TrainingPrivate Training

A customizable, cost-effective solution for groups of 5 or more. Contact us to learn more »

Private TrainingGroup Discount Save up to 25%

Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).

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

Can't travel? This class is also available virtually.

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.

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.800.472.6477  |  Private training available, learn more »

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (PM) 06/22/2020 5 $2495.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 08/10/2020 5 $2495.00 Add to Cart CONTACT US
San Francisco Area, CA 08/25/2020 3 $2495.00 Add to Cart CONTACT US
San Jose, Costa Rica 09/02/2020 3 $2495.00 Add to Cart CONTACT US
Ann Arbor, MI 09/09/2020 3 $2495.00 Add to Cart CONTACT US
Edison, NJ 09/15/2020 3 $2495.00 Add to Cart CONTACT US
Orlando, FL 09/29/2020 3 $2495.00 Add to Cart CONTACT US
San Diego, CA 10/13/2020 3 $2495.00 Add to Cart CONTACT US
San Francisco Area, CA 12/02/2020 3 $2495.00 Add to Cart CONTACT US

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
  • Identify opportunities beyond compliance, including FDA’s Case for Quality

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
  • Going beyond the minimum requirements, including FDA's Case for Quality

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. 

In-Person Days: 3
CEUs: 2.5

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.

Online Training Schedule

This training is delivered as five 3.5 hours sessions.  Each session is a combination of subject matter expert and group discussions, interactive whiteboards, polls, and chat rooms that help students with small group exercises, making this an engaging, interactive learning experience.

Unless otherwise noted, a standard schedule for this class is:

  • Monday 1:30 PM – 5:00 PM
  • Tuesday 1:30 PM – 5:00 PM
  • Wednesday 1:30 PM – 5:00 PM
  • Thursday 1:30 PM – 5:00 PM
  • Friday 1:30 PM – 5:00 PM

Public seminars are run on the Eastern time zone to allow for attendance by Pacific time one attendees. Additional sessions may be offered in other time zones.

Technical /Logistical Requirements

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

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

Private Training Close

The dates you choose. The location you want.
The results you need!

Bring any of our classes to your location - Oriel STAT A MATRIX Private training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

Get answers right now. Call 1.800.472.6477

We use cookies to help us offer you the best online experience. By continuing to use our website or closing this window, you’re providing consent regarding cookies. If you want to learn more read our Privacy Policy.

OK