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THank you, I was asking a loaded question. My new company is in the practice of sending off 510ks before the planning even begins. The process of risk management for example is inherently ingrained into design controls.
I was floored when I was requested to provide a risk management report, 60601 compliance etc. The risk mgmt report alone is an output of activities where we are providing evidence that risk mitigations are effective as well as summarizing testing etc to say the least.
I was floored when I was requested to provide a risk management report, 60601 compliance etc. The risk mgmt report alone is an output of activities where we are providing evidence that risk mitigations are effective as well as summarizing testing etc to say the least.