A risk is an event or condition that, if it occurs, could have a positive or negative effect on a project’s objectives.
Risk Management is defined as the process of recognizing, classifying, evaluating, responding to and managing risks that could appear in any project. This plan is usually created by the project manager. The team members including the project manager and the project sponsor are responsible for what is included in this plan. This plan is normally prepared by the project manager. This plan would make it easier for the team to keep track of any predicted risk project, and to determine the risk impacts and classify it whether it is high (impact project cost/plan/achievement), medium (slight impact), or low (relatively little impact).

ISO 14971 is a required standard by the regulatory authorities for all medical device companies to ensure the risk management process. This standard would assist the risk management process in a medical device company in identifying hazards, and in estimating the risk.

I found these few key definitions on greenlight.guru useful to learn:

“RISK – combination of the probability of occurrence of harm and the severity of that harm
HAZARD – potential source of harm
HAZARDOUS SITUATION – circumstance in which people, property, or the environment are exposed to one or more hazard(s)
HARM – physical injury or damage to the health of people, or damage to property or the environment
SEVERITY – measure of the possible consequences of a hazard
RISK ANALYSIS – systematic use of available information to identify hazards and to estimate the risk
RISK ESTIMATION – process used to assign values to the probability of occurrence of harm and the severity of that harm
RISK EVALUATION – process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk
RISK ASSESSMENT – overall process comprising a risk analysis and a risk evaluation
RISK CONTROL – process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels
RESIDUAL RISK – risk remaining after risk control measures have been taken”