Loading ...

Public Training Course Dates & Information:

Course Catalog PDF Download Catalog ยป
On-site TrainingOn-site Training

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

On-site 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).

Medical Device Supplier Quality Management Training

Updated to reflect new EU and MDSAP requirements for effective supplier management.

Poorly designed and executed supplier quality management systems can cost your company millions. With dozens or hundreds of suppliers to manage, you need a proven risk-based process that meets FDA and ISO 13485:2016 requirements, plus new mandates found in the EU Medical Device Regulation (MDR 2017/745). On paper, the requirements seem straightforward, but applying them can get tricky.

You’ll walk away from this 3-day training with a clear understanding of the various regulatory requirements and how to establish an effective and efficient system using a risk-based approach.

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  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
San Diego, CA 07/30/2019 3 $2895.00 Add to Cart CONTACT US
Orlando, FL 09/10/2019 3 $2895.00 Add to Cart CONTACT US
Edison, NJ 10/08/2019 3 $2895.00 Add to Cart CONTACT US
Minneapolis, MN 11/12/2019 3 $2895.00 Add to Cart CONTACT US
San Francisco Area, CA 01/28/2020 3 $2895.00 Add to Cart CONTACT US
Chicago, IL 03/17/2020 3 $2895.00 Add to Cart CONTACT US

What You Will Learn

At the conclusion of this workshop, you will be able to:

  • Identify requirements for supplier quality management, including ISO 13485:2016, US FDA, MDSAP, and the EU MDR.
  • Establish a risk-based process for evaluating, selecting, and reevaluating your suppliers.
  • Translate needs into purchased product and supplier requirements.
  • Develop and maintain an Approved Supplier List and manage your outsourced processes.
  • Understand the elements of a good quality agreement and when they are needed.
  • Implement an effective process for verifying purchased product and monitoring ongoing supplier performance.
  • Manage supplier nonconformances, escalation of issues, and supplier change notification.
  • Create clear product specifications and head off potential issues before they occur.
  • Identify and resolve supplier issues before they escalate.

Who Should Attend

Anyone involved in sourcing, securing, and maintaining critical suppliers and services that affect product quality and organizational reputation. Attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485. 

Number of Days: 3
CEUs: 2.5
On-Site 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 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 1.800.472.6477 or Contact Us.

Get answers right now. Call 1.800.472.6477