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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.

The ISO 24971 provides different inputs that can be used as starting point for the evaluation of the residual risks, for examples: Different sequences of events can lead to different hazardous situations and risks, each contributing to the overall residual risk.

What is the difference between ISO 13485 and ISO 14971? ISO 13485 focuses on quality and customer requirements for medical devices, whereas ISO 14971 focuses primarily on safety, security, and risk associated with the use of medical devices.

ISO 14971, recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. IEC 62304:2006, makes a normative reference to ISO 14971 requiring its use.

ISO 13485 (3rd Edition).

ISO 13485 requires risk-based thinking regarding QMS processes (sub-clause 4.1. 2) and risk management with regard to patient/end-user safety in using the medical device (clause 7.1).

To maximize effectiveness of your risk management system, ISO 14971 can and should be an integral part of your quality management system (QMS) as required by ISO 13485. Specific requirements of ISO 14971 include: Provision of adequate resources. Assignment of qualified personnel.

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.