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  • gy66 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 7 months ago

    I absolutely agree, at first I, I too felt surprised how ineffective labels and warning are the least effective in preventing residual risk in our products. In our case at work, there are currently a couple of “exploits” in our software that allows the customer to either produce a part for much cheaper or request a part that is simply unproducible on our end. Although we attempt to enforce guidelines for our customers to follow and warnings to avoid these exploits, it is almost inevitable to receive such cases. Some measures we’ve taken in addition to the instructions for use is incorporate simple and minor “roadblocks” in the exploited workflows to prevent our customers from being able to follow through. This however adds a step to other normal workflows which makes it slightly more inconvenient for other customers. From my perspective, it seems like incorporating instructions of use, labels, or even slight modifications to prevent residual risk either fails to do so or presents some risk in another way. Perhaps larger modifications are needed to completely eliminate the targeted residual risk without creating some risk elsewhere.