ISO 14971:2019: The Evolution and Definitions

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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. In this course we will focus on the scope of the standard.

Curriculum for this course:

Program Introduction

Overview	1 min 01 secs
Learning Objectives	1 min 31 secs
Who Will Benefit from This Training?	1 min 21 secs
Materials Used	1 min 10 secs
Program Overview	1 mins 11 secs
Course Introduction	1 min 09 secs
Course Overview	1 mins 10 secs
Learning Objectives	1 mins 22 secs

A Short History

Always Managing Risk	1 min 05 sec
:2007 / :2012 and the Zeds and Evolution – Part 1	1 min 10 secs
:2007 / :2012 and the Zeds and Evolution – Part 2	1 min 08 secs

Other Changes Since the :2007 Version

The Definitions	1 min 20 secs
Benefit	1 min 10 secs
Harm	1 min 02 secs
Intended Use	1 min 25 secs
Manufacturer	1 min 10 secs
Reasonably Foreseeable Misuse	1 min 09 secs
State of the Art	1 mins 23 secs
The Biggest Change	1 min 11 secs
Other Changes of Note – Part 1	1 min 14 secs
Other Changes of Note – Part 2	1 min 01 secs