ISO 14971 is widely recognized as the official standard for medical device risk management. Regulators in most major markets expect medical device manufacturers to use this standard to manage risk.

Often times, it is assumed that the topic of Risk Management is only the responsibility of the medical device product developers and engineers designing new products. But, medical device Risk Management is a much more comprehensive process that should span all functional areas of a medical device.

The process itself includes:
risk management plan
hazard identification
risk analysis
risk control option analysis
verification of risk control effectiveness
risk / benefit analysis
risk management report

Risk Management is a total product lifecycle process. Unfortunately, risk management efforts have a tendency to trail off and be forgotten once a product is launched.

We are determined to create Risk Management File needs to be a living document.

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