Based on the results of your Risk Evaluation, you will need to identify Risk Controls. Risk Controls are measures that you take with your medical device to reduce the identified potential risk(s) and/or their impact. ISO 14971 requires the manufacturer to “identify risk control measure(s) that are appropriate for reducing the risk(s) to an acceptable level. The manufacturer shall use one or more of the following risk control options in the priority order listed: a) inherent safety by design; b) protective measures in the medical device itself or in the manufacturing process; c) information for safety.” The criteria for risk control should be included in your Risk Management Plan, and the results stored in the same place.
There are various techniques that can be used when addressing Risk Control:
- Avoidance – avoid the risk completely
- Risk Prevention – instead of avoiding a risk completely this approach will minimize the risk
- Risk Reduction – accepts the risk but seeks to minimize it
- Segregate – isolate or segregate to ensure positive control of the issue
- Duplication – create a “backup” option
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