![]() ![]() The tables below show some common tools you can use to evaluate risk. It would take far too long to go into depth about the options available to you. The one(s) you use will depend on your product and company culture, among other things. There are many options, each with pros and cons. Unless you have prior experience with risk management, it can be perplexing to figure out which risk evaluation tools are best suited to your situation. ![]() This also includes implementation and verification of risk control measures, and an assessment of the acceptability of residual risk. Your risk management file must include evidence that you have conducted a risk analysis and risk evaluation for each identified hazard, including foreseeable risks. You will confront the following questions: Clause 7 of ISO 14971 is all about risk control. Once you have identified the risks, analyzed their severity, and assessed their likelihood to occur, it’s time to look at how those risks can be controlled. Remember, you cannot trade off safety for cost! ![]() In your risk management file, document the hazards you identify and the rationale behind the decision to control or not control those risks. To avoid making the wrong decision, evaluate risks using a disciplined, planned process.
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