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sin3 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 6 years, 4 months ago
Nowadays, people are willing to sue over anything and anyone. Therefore, companies must take all measures in avoiding, mitigating, transferring, and accepting risks without having any legal issues arise. However, there is a limit for how far a company can go to prevent risk, depending on the product and audience it targets. A company should only need to examine and assess risks that are within common sense, not anything below. Like one of my classmates has said, if given a device with an electrical component to it used by surgeons, the company does not need to caution the surgeons to prevent submersion of the device in water. The limit companies must go for manufacturers to reduce risks must fall within common sense and recognition of who the end-user’s are.