The Medical Devices Introductory Course 2020

ISO 14971:2019 Risk Management for Medical Devices

The Organisation for Professionals in Regulatory Affairs

ISO 14971: 2019 Overview

ISO IEC Directives, HLS (Annex L) ISO31000:2018 & ISO 9000:2015

Not intended for managing product related risk

Effect of uncertainty on objectives. Note 1 to entry: An effect is a deviation from the expected. It can be positive, negative or both, and can address, create or result in opportunities and threats

Focus on organizational risk

ISO 14971:2019 ISO 13485:2016

Organizational risk/business risk is out of the scope of ISO 14971

Combination of the probability of occurrence of harm and the severity of that harm

Focus on product safety risk

The Organisation for Professionals in Regulatory Affairs