1SO 14971:2019

ISO 14971:2019: Basic Framework for Risk Management

The learning objectives for this module are to set the foundation regarding the basics of risk management. We will point out that there are multiple tools that can facilitate risk management. We will provide a useful approach to Risk Management planning and discuss organization of the risk file. The specific sections in this module include, Risk Management Framework, Toolbox, [4.4] Risk Plan and [4.5] Risk Management File.

CEU Credits: 0.1

Course Code: ELM-335

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Program Introduction

Overview

Learning Objectives

Who Will Benefit from This Training?

Materials Used

Program Overview

Course Introduction

Course Overview

Learning Objectives

Risk Framework

Risk Estimation – Severity

Risk Estimation – Probability

How to Score the Risk

Risk Acceptability

Toolbox

Fault Tree Analysis

Ishikawa or Fishbone Diagram

Risk Management Plan

Scope

Assignment of Responsibilities and Authorities – Part 1

Assignment of Responsibilities and Authorities – Part 2

Risk Management Activities

Requirements for Review of Risk Management Activities

Criteria for Risk Acceptability

Method to Evaluate the Overall Residual Risk

Verification Activities

Activities Related to Collection and Review of Relevant Production and Post-Production Information

Relationship to Other Plans

Integration

Risk Management File

Risk File

Traceability

Family of Devices

Conclusion

Final Exam

Certification

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group

Courses

Browse our extensive catalog of GxP, Corporate Compliance and EH&S training.

Learning Strategy

Boost your organization’s training with LearnGxP’s Learning Strategy Consultants (LSC). They customize learning paths to match your needs, offering ongoing support for lasting success.

Customer Stories

Discover how LearnGxP addresses real challenges, provides effective solutions, and positively impacts our customers’ organizations.