What is the ISO 14971 standard?
ISO 14971 provides internationally recognized guidelines for risk management in the design and development of medical devices.
It can be used by various stakeholders to develop, manufacture, regulate and monitor devices, while ensuring their safety for end users.
A copy of the standard is available for purchase from the ISO site.
A brief overview of ISO 14971
ISO 14971 is a nine-part standard that outlines requirements and a recommended process for risk management.
The current version of the standard, ISO 14971 Medical Devices – Application of Risk Management to Medical Devices, was released in 2019. This is the fourth version in the series.
The standard was first launched in 2000, and supersedes two earlier versions of the standard – ISO 14971: 2007 and EN ISO 14971: 2012.
The former 14971: 2007 standard related to the manufacture of medical devices worldwide. The EN ISO 14971: 2012 standard applied to organizations involved in the distribution and sales of medical devices in Europe.
The objective of the latest version of ISO 14971 is to help medical device manufacturers identify, evaluate, control and monitor risk throughout the entire product lifecycle.
The standard has been widely adopted by regulatory authorities across the world.
Difference between ISO 13485 and ISO 14971
ISO 13485 is concerned with quality management of medical devices.
It establishes guidelines for the development of a quality management system (QMS) to ensure compliance with regulatory and customer requirements.
ISO 14971 addresses risk and safety requirements relating to the use of medical devices.
Is ISO 14971 recognized by the FDA?
The FDA, along with a host of other regulatory bodies, recognizes ISO 14971 as an appropriate risk management model.
It has categorized the latest edition of the ISO 14971 risk management standard as a “Recognized Consensus Standard” for medical devices.
Is compliance with ISO 14971 mandatory?
Compliance with the ISO 14971 is voluntary in the United States. No formal accreditation is associated with conformity.
That said, the standard is considered best manufacturing practice for medical device companies.
The European Union has made compliance with the standard mandatory.
