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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

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 Course Private
VIRTUAL DELIVERY (PM) 08/10/2020 5 $2495.00 Add to Cart CONTACT US
Ann Arbor, MI 09/09/2020 3 $2495.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 10/12/2020 5 $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 consecutive half-day sessions.
  • Daily sessions run from 1:30-5:00 p.m. Eastern Standard 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:

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

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:30-5:00 p.m. EST (3.5 hours each day).

Auditor classes that that require a final exam are extended by 2 hours on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

Get answers right now. Call 1.800.472.6477

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