1SO 14971:2019

ISO 14971 – The Scope of the Standard

Risk management for medical devices is an absolute requirement worldwide. The review of the Risk Management File is getting a critical and thorough assessment by regulatory bodies. Beyond that, good Risk Management just makes good business sense. Nobody wants their device to harm patients and there can be severe financial repercussions if devices do cause harm. ISO 14971:2019 is the latest version of the most generally accepted standard for medical device risk management. This program is tailored around that standard. In this course we will focus on the scope of the standard.

CEU Credits: 0.1

Course Code: ELM-333

Duration: 30 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V2.1

Effective Date: 09/27/2021

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

Section 1: Scope

Always Managing Risk

An Holistic Approach

Section 2: Normative References

Normative References

Section 3: Terms and Definitions

Benefit

Harm & Hazard

Hazardous Situation

Reasonably Foreseeable Misuse

Residual Risk, Risk and Risk Control

State of the Art

Use Error

Revisiting Section 1: Scope

Is / Is Not

Where it Fits

Expectations from 60601

Integration with Usability Engineering

Integration with Software Development

Section 4: General Requirements for Risk Management Systems

Section 4.1 Risk Management Process – Part 1

Section 4.1 Risk Management Process – Part 2

Section 4.2 Management Responsibility – Part 1

Section 4.2 Management Responsibility – Part 2

Section 4.3 Competence of Personnel – Part 1

Section 4.3 Competence of Personnel – Part 1

Conclusion

Final Assessment

Certification

Revision History

Minor update to fix assessment functionality and update to new navigation standards.

V2.1

Course updated to fix assessment functionality and course functionality.

V2.0

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group

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