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BijinV replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
I believe the concept of as far as possible is meant to be vague. It isn’t defined as a certain level of safety or risk mitigation. Because by defining the point at which risk is “adequately” mitigated would lead to the requirement being met, but just barely. I believe the concept of as far as possible is meant to be a challenge and a charge to any company to do everything they can within their power to create a device with as low a possibility of risk or harm to its users as possible.