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ISO 14971 Medical Device Risk Management Training

Can't travel? This class is available virtually.

The EU medical device regulations, the MDSAP audit model, and the new version of ISO 14971:2019 have put a spotlight on risk management as a foundational process in your quality management system. How companies manage risk associated with their devices throughout the product life cycle is getting more scrutiny from regulators.

In this workshop-based course you will learn how to apply ISO 14971:2019 risk management from:

  • A product focus – how to apply or “do” the risk management process through a device’s full life cycle (development through end of life).
  • A process focus – how to treat risk management as a foundational process of your quality management system, and how it integrates with other key processes (design control, production and service controls, feedback, improvement, management responsibility, etc.).

This course also includes basic risk management considerations for 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 1.800.472.6477  |  Private training available, learn more »

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (PM) 06/01/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 06/22/2020 5 $2995.00 Add to Cart CONTACT US
Austin, TX 07/08/2020 3 $2995.00 Add to Cart CONTACT US
Minneapolis, MN 07/22/2020 3 $2995.00 Add to Cart CONTACT US
San Diego, CA 08/18/2020 3 $2995.00 Add to Cart CONTACT US
San Francisco Area, CA 09/01/2020 3 $2995.00 Add to Cart CONTACT US
Ann Arbor, MI 09/22/2020 3 $2995.00 Add to Cart CONTACT US
Edison, NJ 09/22/2020 3 $2995.00 Add to Cart CONTACT US
Orlando, FL 10/13/2020 3 $2995.00 Add to Cart CONTACT US
Raleigh, NC 11/03/2020 3 $2995.00 Add to Cart CONTACT US
Edison, NJ 12/01/2020 3 $2995.00 Add to Cart CONTACT US
Chicago, IL 12/15/2020 3 $2995.00 Add to Cart CONTACT US

What You Will Learn

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

  • Identify integration of risk into the European Union (EU) Medical Device Regulation (MDR), the Medical Device Single Audit Program (MDSAP), and the US FDA quality system regulation (QSR).
  • Describe the purpose, structure, and key concepts of ISO 14971 and ISO/TR 24971, including the definitions for benefit, state of the art, and reasonably foreseeable misuse and the expanded requirements for production and post-production activities.
  • Understand the relationship of ISO 14971 to ISO 13485, IEC 60601, IEC 62304, IEC 62366, and ISO 10993.
  • Identify software risk management expectations in IEC 62304, including the application of ISO 14971 to software (ISO/TR 80002-1), and current US FDA guidances for cybersecurity and SaMD.
  • Articulate the requirements for each step of the risk management process, including risk management planning, risk analysis, risk evaluation, risk control, benefit-risk and residual risk analysis, risk management review and reporting, and production and post-production activities.
  • Through workshops, create a risk management plan, apply tools for risk assessment and risk control, conduct a benefit-risk analysis, create a risk management report, and assess production and post-production information for possible action.
  • Understand production and post-production risk management requirements, including CAPA activities and postmarket surveillance processes.
  • Describe how to use the process and risk-based approach of ISO 13485 to ensure the continued suitability, adequacy, and effectiveness of your risk management process

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. 

In-Person Days: 3
CEUs: 2.5

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

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.

A typical schedule for this class is Monday through Friday from:

  • 1:30 PM to 5:00 PM (Eastern US time)
  • 12:30PM to 4:00PM (Central US time) 
  • 11:30AM to 3:00PM (Mountain US time)
  • 10:30AM to 2:00PM (Pacific US time) 

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

We may also from time to time offer sessions that run daily from 8:30 AM to 12:00 PM.

Technical /Logistical Requirements

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

Tablets and mobile devices may lack some essential functionalities and are not recommended.

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

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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.

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