This standard specifies terminology, principles and a process for risk management for medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this standard intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of this standard are applicable to all phases of the life cycle of a medical device. The process described in this standard applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.

Risk management for Medical devices is a complex subject because a different value on the acceptability of risks in relation to the anticipated benefits.

It is generally accepted that the concept of risk has two key components:

• The Probability of occurrence of harm; and
• The Consequences of that harm, that is, how severe it might be

The use of a medical device involves an inherent degree of risk, even after the risks have been reduced to an acceptable level. It is well known that in the context of a clinical procedure some residual risks remain. The acceptability of a risk is influenced by the key components and by the perception of the risk and the benefit. Each perception can vary depending upon the cultural background, the socio-economic and educational background of the society concerned and the actual and perceived state of health of the patient. The way a risk is perceived also takes into account other factors, for example, whether exposure to the hazard or hazardous situation seems to be involuntary, avoidable, from a man-made source, due to negligence, arising from a poorly understood cause, or directed at a vulnerable group within society.

Risk Management for Medical devices requires top management involvement. It requires that a company establish a Risk Management Policy.

The process itself includes:

1. Risk Management Planning
2. Risk Analysis
3. Risk Evaluation
4. Risk Controls
5. Overall Residual Risk Acceptability
6. Risk Management Review
7. Production & Post-Production Information

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