Positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health (EN ISO 14971:2019-Section 3.2)
Injury or damage to the health of people, or damage to property or the environment
Circumstance in which people, property or the environment is/are exposed to one or more hazards. (EN 14971:2019- Madde 3.5)
Risk remaining after risk control measures have been implemented. (EN ISO 14971:2019 Article 3.17)
In every medical device from software to implant, there are common challenges with application, design, and process. Risk management is the forecasting and assessment of those challenges, as well as the detection of procedures to prevent or mitigate their effects. EN ISO 14971:2019 standard illustrates how to incorporate an effective risk management system for medical devices. (AdviQual Definition)
A medical device has to have more benefits than its risks; therefore, during and after the product development, the manufacturer has to make an active risk/benefit assessment and ensure that the device’s benefit exceeds the risks. (AdviQual Definition)
Potential source of harm (EN 14971:2019- Article 3.4)
Use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behaviour. (EN ISO 14971:2019 Article 3.15)
Process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels.
Freedom from unacceptable risk.
