IMPLEMENTATION OF RISK MANAGEMENT FOR MEDICAL DEVICES

ISO 14971 is a “Risk Management” standard. It covers not only the risk determination activities but encompasses the whole application of risk to overall activities. This includes all activities of the medical device lifecycle:

Design
Manufacturing
Installation
And servicing

As part of the risk management process it is necessary that you have Risk Analysis, Risk Evaluation, Risk Control and Monitoring. If your company is doing only one or several of these but not ALL then you do not have an effective risk management process implemented.

An error many manufacturers make is to failing to include all elements of the risk management process. Many believe mistakenly that if they have a Risk Assessment process that they are covered. Risk assessment is defined as the processes of Risk analysis (Hazard identification, risk estimation) and risk evaluation (Risk acceptability decisions). However, risk management also includes risk control (option analysis, implementation, residual risk evaluation and overall risk acceptance), AND post-production information (post production experience, and review of risk management experience).

ACCEPTANCE OF ISO 14971 STANDARD

Recently the US FDA has recognized ISO 14971 as providing a basis for risk assessment. Until now the standard was seen as an acceptable means of managing risk.

Health Canada requires manufacturers to comply with ISO 13485 which indirectly (only stated in footnote) that ISO 14971 is the standard of choice for dealing with risk.

When all things are considered the choice of ISO 14971 as a basis for your risk management standard should be very much considered. The rest of this article assumes an approach based on this standard.

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