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On-site TrainingOn-site Training

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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

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

Now includes an introduction to the Medical Device Single Audit Program (MDSAP) and FDA's Case for Quality.

At the end of this 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 1.888.532.6360  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
Raleigh, NC 04/30/2019 3 $2495.00 Add to Cart CONTACT US
Orlando, FL 05/20/2019 3 $2495.00 Add to Cart CONTACT US
San Diego, CA 06/04/2019 3 $2495.00 Add to Cart CONTACT US
Chicago, IL 06/18/2019 3 $2495.00 Add to Cart CONTACT US
San Jose, Costa Rica 06/24/2019 3 $2495.00 Add to Cart CONTACT US
Edison, NJ 07/09/2019 3 $2495.00 Add to Cart CONTACT US
Minneapolis, MN 07/23/2019 3 $2495.00 Add to Cart CONTACT US
Boston, MA 08/06/2019 3 $2495.00 Add to Cart CONTACT US
San Francisco Area, CA 08/20/2019 3 $2495.00 Add to Cart CONTACT US
Edison, NJ 09/10/2019 3 $2495.00 Add to Cart CONTACT US
Orlando, FL 09/24/2019 3 $2495.00 Add to Cart CONTACT US
San Diego, CA 10/08/2019 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. 

Number of Days: 3
CEUs: 2.5
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The dates you choose. The location you want.
The results you need!

Bring any of our classes to your location - Oriel STAT A MATRIX on-site 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 1.888.532.6360 or Contact Us.

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