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ISO 14971 Medical Device Risk Management and Analysis Training

How companies manage risk associated with their devices throughout the product life cycle is getting more scrutiny from regulators. The EU Medical Device Regulation, MDSAP Audit Model, and the latest versions of ISO 14971 and ISO/TR 24971 have put a spotlight on risk management as a foundational process in your quality management system. In this course you will learn the importance of applying ISO 14971:2019 from a product focus through a device’s full life cycle. Learn how to treat risk management as a foundational process of your quality management system, and how it integrates with other key processes. We also offer an ISO 14971 class for combination products and one focused on device cybersecurity risk.  

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We Offer Two ISO 14971 Risk Training Classes. Which One is Right for You?

SkillsLab Class ?
DaySmart Class ?

Class Content

In-Depth

Foundational Overview

Class Duration

5 Half-Day Sessions*

6 Hours (One Day)

Teaching Format

Live, Instructor-Led

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Virtual or In Person**

Certification of Completion

Yes

Yes

Continuing Education Units (CEUs)

2.5

0.6

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Medical Device Risk Training Courses

SkillsLab $2995 DaySmart $995

SkillsLab $2995

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

DaySmart $995

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

ISO 14971:2019 Training: How Deep Do You Need to Go?

Our DaySmart option provides a foundational overview of the risk analysis process. You’ll walk away with a solid understanding of the essentials of compliance. Our SkillsLab class goes deeper into more areas of risk management,with additional hands-on exercises to apply your knowledge. See the table below and choose the option that fits your needs.

 

Course Overview
SkillsLab Class
DaySmart Class

Risk Management Concepts, Standards, Requirements

  • Review the basic terms and evolution of risk management in the global regulatory community
Case study! Describe Device (Intended Use, Users, Benefits)

The Risk Management Process

  • Risk considerations in ISO 13485:2016, MDSAP, the EU device regulations (EU MDR and IVDR), and US FDA QSR
  • Purpose of the risk policy
  • Risk management as a QMS process

ISO 14971:2019 Overview

  • ISO 14971:2019 and ISO/TR 24971:2020
  • The risk management process described in ISO 14971:2019
  • Define key terms, including reasonably foreseeable misuse, hazards, hazardous situations, and harms
Case Study! Questions to Ask 

Risk Management Planning

  • Risk management procedure
  • Risk management plan and its maintenance
  • Risk acceptability criteria
Case Study! Risk Management Plan

Risk Assessment and Risk Analysis

  • Risk assessment
  • Risk analysis
  • Intended use and reasonably foreseeable misuse
  • Characteristics related to safety
  • Hazards, hazardous situations, and harm
Case Study! Risk Analysis

Risk Analysis, Risk Estimation and Evaluation

  • Risk estimation
  • Probability and severity
  • Risk evaluation
Case Study! Risk Analysis

Risk Management Tools

  • Choosing risk tools 
  • Design and Process FMEA
  • Preliminary hazard analysis
  • Fault tree analysis
  • Hazard analysis and critical control point (HACCP)
  • Hazard and operability analysis (HAZOP)
Case Study! Risk Analysis, Apply Tools

Risk Control

  • Approaches to risk control: ISO 14971, US, EU
  • Risk control process
  • Option analysis
  • Implementation of risk controls
  • Residual risk evaluation
Case Study! Risk Controls

Examining Benefits vs. Risks

  • Benefit-risk analysis and ISO 14971:2019
  • Approaches to benefit-risk: US and EU

Risk Control Completion, Overall Residual Risk Evaluation

  • Risk control and the benefit-risk analysis
  • Impact of risk controls
  • Evaluation of overall residual risk
Case Study! Benefit-Risk

Production and Post-Production Risk Management Activities

  • Risk management review
  • Risk management report
  • Production and post-production activities;
  • Incident- and review-driven activities
  • Information collection and review
Case Study! Risk Management Report
Case Study! Post-Production Information
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab
DaySmart

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 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. 

Describe the risk management process, including planning, analysis, evaluation, control, benefit-risk and residual risk analysis, risk management review and reporting, and production and post-production activities. 

Identify 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. 

Apply the concepts and requirements of ISO 14971 to create risk management activities and documents supporting the activities that contribute to providing and establishing  the safety and effectiveness of the medical device. 

Who Should Attend

Who Should Attend

Recommended for design managers and engineers; manufacturing, service, quality assurance, reliability, research and development, internal auditors, 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.

  • Internal Auditors
  • Research and Development
  • RA/QA Professionals
  • PMS Managers
  • Engineering Teams

 

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