Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk.

Although risk is a variable we encounter in everyday life, it means something uniquely different to the medical device industry. Risk is a critical factor to consider throughout the life cycle of a medical device because it can mean the difference between life and death for patients.

Industry resources like ISO 14971 exist to help medical device professionals define and clarify risk management best practices. According to the internationally recognized standard for medical device risk management, risk is defined as “the combination of the probability of occurrence of harm and the severity of harm.”

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