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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).

ISO 14971 Medical Device Risk Management Training

Recent changes in EU medical device regulations and increased scrutiny by the US FDA have put a spotlight on risk management. There is more emphasis on total life-cycle management than ever before.

During three information-packed days of interactive workshops and group discussions, you will learn to evaluate whether risks and benefits are appropriately balanced. We also delve into risk management requirements in MDSAP and the new EU Medical Device Regulation, and examine expectations for embedded software, SaMD, and cybersecurity. 

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
Boston, MA 06/18/2019 3 $2895.00 Add to Cart CONTACT US
Irvine, CA 07/09/2019 3 $2895.00 Add to Cart CONTACT US
Chicago, IL 07/23/2019 3 $2895.00 Add to Cart CONTACT US
Edison, NJ 08/06/2019 3 $2895.00 Add to Cart CONTACT US
San Francisco Area, CA 08/20/2019 3 $2895.00 Add to Cart CONTACT US
Indianapolis, IN 09/10/2019 3 $2895.00 Add to Cart CONTACT US
Orlando, FL 09/24/2019 3 $2895.00 Add to Cart CONTACT US
Minneapolis, MN 10/01/2019 3 $2895.00 Add to Cart CONTACT US
San Diego, CA 10/08/2019 3 $2895.00 Add to Cart CONTACT US
San Jose, Costa Rica 10/23/2019 3 $2895.00 Add to Cart CONTACT US
Boston, MA 11/05/2019 3 $2895.00 Add to Cart CONTACT US

What You Will Learn

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

  • Understand global regulatory compliance requirements, including those specific to the EU MDR, MDSAP, and US FDA.
  • Describe the purpose, structure, clauses, and key concepts of ISO 14971:2007 and related standards, and understand content deviations with EN ISO 14971:2012.
  • Articulate the requirements for each step of the risk management process, including risk management plan, risk analysis, risk evaluation, risk control, risk benefit, risk management file, and post-production analyses.
  • Create a risk management plan, apply tools for risk assessment and risk control, conduct a risk-benefit analysis, and create a risk management report.
  • Identify software risk management expectations in IEC 62304 and the application of ISO 14971 to software (ISO/TR 80002-1).
  • Understand post-production risk management requirements, including reactive CAPA activities and proactive postmarket surveillance.

Who Should Attend

Recommended for design managers and engineers; manufacturing, service, quality assurance, reliability, research and development, and regulatory affairs professionals; and other cross-functional team members in a medical device environment. All attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485. 

Number of Days: 3
CEUs: 2.5
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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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