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  • zmh4 replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 7 years, 7 months ago

    I would have to disagree with most people on here. These regulations should not cost any money. There should be a standard set of rules that all companies should follow, similar to the way the FDA has guidelines for medical devices and holds certain standards for them before they are put in the market. These rules are important for safety, and money should not hinder a company or organization from finding information on how to provide this safety to their consumers. In my opinion, a company should pay when the safety guidelines are not met, as sort of a fee and their products should not be allowed to be marketed if found that the product has too many risks. The company’s quality engineers should be well trained in being familiar with these guidelines and be able to enforce them properly.