The Medical Device Risk Management Standard - What’s New with ISO 14971:2019?

by Michael B. Checketts published on November 21, 2019

Risk management plays a prominent role in the development of medical devices and 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.

The “high-level clause structure” of this standard now conforms to the ISO-mandated ten clauses. All new or revised management system Standards published by ISO going forward must use the same ten high-level clause names, numbers and use specified definitions and some common text. Those familiar with international standard formats (within ISO/ANSI/AAMI), will have familiar ground when perusing through ISO 14971:2019.

There is further alignment with changes being made to other national standards, such as ISO/IEC directives in general and specifically Guide 63:2019 & 51:2014, ISO 18113- 1:2009, ISO 9000:2015, ISO 13485:2016, ISO 31000:2018, ISO 10993-1, IEC 60601-1, IEC 62366-1:2015 and ISO 24971:2019. There are of course more, but these are of particular interest.

Management Responsibilities for device makers have expanded in ISO14971:2019 to include approaches for risk control wherein reducing risk as low as reasonably achievable is now a direct responsibility. Reviewing production and postproduction information as an input to the risk management process (clause 4.2) is now a requirement. Multiple clarifications are also made in clause 9, to help in the Risk Management Review prior to the commercial release of the product.

Download this article by our top consultant, Michael B. Checketts, to get a full glimpse of the Medical Device Risk Management Standard and its notable changes with ISO 14971:2019. 

Michael Checketts

Michael Checketts is a Senior Manager with extensive Engineering, Quality, and Regulatory management experience. Whether it may be in Product Development, Manufacturing, or Quality Management Systems, his greatest desires are to improve manufacturability & time to market. He also well understands the need for reducing costs while continually improving quality & compliance/conformance. Michael is a certified Lead Auditor for ISO 13485:2016, ISO 14001:2015, ISO 17025:2017, and ISO 9001:2015.