Understanding the Importance of ISO 14971

18 April 2011

On the April 4 blog, we took a closer look at how software developers must implement a risk management system – specifically, a risk management system established to the ISO 14971 standard. But what really does ISO 14971 cover and why is it important to manufacturers, health care providers and regulatory bodies?

Over the last decade, it became evident that the process of managing risk – as well as the balancing of risks and benefits for all medical devices – needed to be addressed. As a direct result, an international risk management standard had to be implemented. But why and how?

The risks that derive from the increasing diversity of medical devices and those applications cannot be completely addressed through product safety standards. The realization of these facts coupled with the consequent need to manage risks from medical devices throughout an entire product life-cycle – as well as its increased importance to regulators – led to the collaborative effort of the ISO and the IEC in developing ISO 14971. ISO 14971 was officially published in 2007.

ISO 14971 outlines a clear process for manufacturers to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to:

  • Estimate and evaluate the associated risks;
  • Control these risks, and
  • Monitor the effectiveness of the controls.

As risks can (and often are) introduced throughout the product lifecycle, the risk management standard covers the medical device from its initial conception until its ultimate decommissioning and disposal.

But what are some of the factors that the ISO 14971 standard does not cover? In our May 2 blog, we'll address this topic.

To speak with an Intertek expert on this subject matter, please send an e-mail to us at askmedical@intertek.com