1SO 14971:2019

ISO 14971: Characterizing the Device & Identifying Hazards

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.

CEU Credits: 0.1

Course Code: ELM-336

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 Analysis

Section 5.1 Risk Analysis Process

Section 5.2 Intended Use and Reasonably Foreseeable Misuse – Part 1

Section 5.2 Intended Use and Reasonably Foreseeable Misuse – Part 2

Section 5.2 Intended Use and Reasonably Foreseeable Misuse – Part 3

Section 5.3, Identification of Characteristics Related to Safety

Section 5.4 Identification of Hazards and Hazardous Situations – Part 1(a)

Section 5.4 Identification of Hazards and Hazardous Situations – Part 1(b)

Risk Register

Organization

Conclusion

Final Assessment

Certification

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group

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