What is the current ISO 14971 standard?
ISO 14971:2019 is a risk management standard but it’s not just about risk reduction. Increasingly regulators want to know more about the benefits your medical device offers. ISO 14971:2019 defines benefits in a way ISO 14971:2007 and EN ISO 14971:2012 did not.
Is ISO 14971 required?
ISO 14971 is a standard for the application of risk management methods for the safe use of medical devices throughout their life-cycle. ISO 13485 Clause 7.1, Planning for product realization states that: ‘Further information can be found in ISO 14971’. This means that the use of ISO 14971 is not mandatory.
What is ISO 14971 and the process of the risk analysis defined in it?
Risk per ISO 14971 is defined as the combination of the probability of occurrence of harm and the severity of that harm. The intent behind Risk Management is to identify, evaluate, analyze, assess, and mitigate potential product issues. Risk Management is a total product life cycle process.
What is the purpose of ISO 14971?
ISO 14971:2019 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire lifecycle of a device.
What are the differences between ISO 14971 2012 and ISO 14971 2019?
The EN version of ISO 14971:2019 will not be harmonized with the Medical Devices Directive (MDD). However, it is not yet harmonized with EU MDR, though BSI has declared it to be the “state of the art” risk management standard for medical devices and therefore replaces the 2012 EN version.
Why is ISO 14971 important?
The intent of ISO 14971 is to define a standard process for identifying risks associated with medical devices at all stages in a device’s life cycle, from product design to procurement to production and postmarket use.
What changed in ISO 14971?
Has ISO 14971 2012 been withdrawn?
While the previous EN ISO 14971:2012 still exists, it is no longer “state of the art” as a risk management standard for medical devices, with the release of the 2019 edition.