Loading ...

Public Training Course Dates & Information:

Course Catalog PDF Download Catalog »
Private TrainingPrivate Training

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

Private 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).

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 and ISO/TR 24971 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.

Just need a quick update on changes in ISO 14971:2019? Check out this class instead.

 

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 10/19/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 11/16/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 12/14/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 01/18/2021 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 02/15/2021 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 03/15/2021 5 $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 consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time (EST).
  • 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:

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.

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 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

We use cookies to help us offer you the best online experience. By continuing to use our website or closing this window, you’re providing consent regarding cookies. If you want to learn more read our Privacy Policy.

OK