ISO 14971: Characterizing the Device & Identifying Hazards

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Description:

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.

Curriculum for this course:

Program Introduction

Overview	1 min 10 secs
Learning Objectives	1 min 31 secs
Who Will Benefit from This Training?	1 min 21 secs
Materials Used	1 min 15 secs
Program Overview	1 min 14 secs

Course Introduction

Course Overview	1 min 05 sec
Learning Objectives	1 min 10 secs

Risk Analysis

Section 5.1 Risk Analysis Process	1 min 12 secs
Section 5.2 Intended Use and Reasonably Foreseeable Misuse – Part 1	1 mins 29 secs
Section 5.2 Intended Use and Reasonably Foreseeable Misuse – Part 2	1 min 21 secs
Section 5.2 Intended Use and Reasonably Foreseeable Misuse – Part 3	1 min 25 secs
Section 5.3, Identification of Characteristics Related to Safety	1 min 10 secs
Section 5.4 Identification of Hazards and Hazardous Situations – Part 1(a)	1 min 09 secs
Section 5.4 Identification of Hazards and Hazardous Situations – Part 1(b)	1 min 30 secs
Risk Register	1 min 11 secs
Organization	1 min 14 secs