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alexandrabuga replied to the topic "Safety Recalls" – 5 years, 11 months ago
I agree with @williamzembricki and @rjs84 that label is crucial and if something happens to the labels that just as important as the product. In some cases FDA requires a certain font to make sure the user can read and… Read more»
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alexandrabuga replied to the topic "When is validation is not required?" – 5 years, 11 months ago
I agree with previous posts like @asimbana mentions that validation is important to determine if device meets user needs and it’s intended use. I like @williamzembricki‘s comment “When in doubt, validate”. I agree that it is necessary for most cases… Read more»
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alexandrabuga replied to the topic Safety Recalls in the forum Introduction to Project Management 6 years, 11 months ago
I agree with @williamzembricki and @rjs84 that label is crucial and if something happens to the labels that just as important as the product. In some cases FDA requires a certain font to make sure the user can read and understand the directions on the label. I think having a problem with labeling on a product especially a device or drug would…[Read more]
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alexandrabuga replied to the topic When is validation is not required? in the forum Introduction to Design Controls 7 years, 5 months ago
I agree with previous posts like @asimbana mentions that validation is important to determine if device meets user needs and it’s intended use. I like @williamzembricki‘s comment “When in doubt, validate”. I agree that it is necessary for most cases especially with medical devices for validation to be done. Validation is key in determining and…[Read more]
