---
title: The Medical Device Risk Management Standard – 9 notable changes with ISO 14971:2019
description: The long awaited Risk Management standard (ISO 14971, 3rd Ed.) was released for publication in late 2019
---

- [Call on : support@example.com](mailto:support@example.com)
- [Call on : 1800 123 45 67](tel:1800%20123%2045%2067)
- Opening Hours Opening Hours : Mon - Fri 8:00 - 18:00 / Sunday 8:00 - 14:00

[![Omnex Insights](https://updates.omnex.com/hubfs/omnex-blue-logo-1.svg "Omnex Insights")](http://new.omnex.com)

# The Medical Device Risk Management Standard – 9 notable changes with ISO 14971:2019

- [Home](https://updates.omnex.com/)
- Blog Details

[Jonathan Hunt](https://updates.omnex.com/en-us/author/jonathan-hunt)  September 01 2020

The turn of the decade isn’t going unnoticed when it comes to medical device standards. The long awaited Risk Management standard (ISO 14971, 3rd Ed.) was released for publication in late 2019. In addition, there is a new companion guidance document released, known as ISO/TR 24971:2019. Technical Reports (TR) are one of the types of documents that ISO publishes. A TR requires less international consensus than their Standards. Also, it is close enough numerically to be remembered as a companion, and not disassociated with ISO14971:2019.

At first glance it seems a loss that the well-used & familiar references (Annexes C, and F – J, see below) were stripped from ISO 14971, and another standard will need to be purchased in order to retain current references. However, by drilling past the surface information of this updated standard, a very logical gold mine of information is provided for us, that hasn’t been previously available.

- [ISO 14971](https://updates.omnex.com/en-us/topic/iso-14971)
- [Medical Devices](https://updates.omnex.com/en-us/topic/medical-devices)
- [Risk Management](https://updates.omnex.com/en-us/topic/risk-management)

#### [Jonathan Hunt](https://updates.omnex.com/en-us/author/jonathan-hunt)

### Submit Your Comment

This is a search field with an auto-suggest feature attached.

- There are no suggestions because the search field is empty.

#### Popular Post

#### [The Medical Device Risk Management Standard – 9 notable changes with ISO 14971:2019](https://updates.omnex.com/en-us/the-medical-device-risk-management-standard-9-notable-changes-with-iso-149712019)

 September 01, 2020

#### [Empower Your Team With Enterprise APQP Solution](https://updates.omnex.com/en-us/empower-your-team-with-enterprise-apqp-solution)

 September 01, 2020

#### [Quality Digest – Relearning the FMEA: AIAG-VDA FMEA](https://updates.omnex.com/en-us/quality-digest-relearning-the-fmea-aiag-vda-fmea)

 September 01, 2020

#### Tag Cloud

[AIAG](https://updates.omnex.com/en-us/tag/aiag) [APQP](https://updates.omnex.com/en-us/tag/apqp) [Coretools](https://updates.omnex.com/en-us/tag/coretools) [Failure Analysis](https://updates.omnex.com/en-us/tag/failure-analysis) [Function Analysis](https://updates.omnex.com/en-us/tag/function-analysis) [ISO 14971](https://updates.omnex.com/en-us/tag/iso-14971) [Medical Devices](https://updates.omnex.com/en-us/tag/medical-devices) [Risk Management](https://updates.omnex.com/en-us/tag/risk-management) [VDA](https://updates.omnex.com/en-us/tag/vda)

#### About Pets

Over 20 years of experience we’ll ensure you always get the best guidance. We serve a clients at every level of their organization we can be most whether as a trusted advisor to top trusted our management coach for fronts line employees.

 Read More

#### Services

- Medical
- Family
- Children
- Education
- Community
- Disaster

#### Usefull Links

- Our Mission
- Financials
- Careers
- Contact
- Store
- Reports

#### Contact Us

5171 W Campbell Ave undefined Kent, Utah 53127 United States

[Mail on : support@example.com](mailto:support@example.com)

[Call on : 1800 123 45 67](tel:18001234567)

Copyright © Omnex India (P) Ltd. 2026. All Rights Reserved

- Privacy Policy
- Terms and Conditions

```json
{
  "@context" : "https://schema.org",
  "@type" : "BlogPosting",
  "author" : {
    "@type" : "Person",
    "name" : "Jonathan Hunt",
    "url" : "https://updates.omnex.com/en-us/author/jonathan-hunt"
  },
  "dateModified" : "2020-09-01T06:42:02.502Z",
  "datePublished" : "2020-09-01T06:42:02.000Z",
  "headline" : "The Medical Device Risk Management Standard – 9 notable changes with ISO 14971:2019",
  "mainEntityOfPage" : {
    "@id" : "https://updates.omnex.com/en-us/the-medical-device-risk-management-standard-9-notable-changes-with-iso-149712019",
    "@type" : "WebPage"
  },
  "publisher" : {
    "@type" : "Organization",
    "logo" : {
      "@type" : "ImageObject",
      "url" : "https://updates.omnex.com/hubfs/omnex-blue-logo-1.svg"
    },
    "name" : "Omnex Inc."
  }
}
```