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mah52 replied to the topic "New Medical Device Project" – 5 years, 11 months ago
I worked on a project to develop a needle that when used by the patient “Does not hurt as much”. That was the user requirement. So in order to asses what that meant or how to change that into product… Read more»
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mah52 posted a new topic "Does Product Classification also depend on the Material of the Product used?" – 5 years, 11 months ago
Suppose that you have a company that makes plastic syringes out of plastic A were to decide “Hey Plastic B is much cheaper lets use that instead”. Would the product classification change? Would there be a need for a PMA… Read more»
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mah52 started the topic Does Product Classification also depend on the Material of the Product used? in the forum Introduction to Project Management 7 years, 2 months ago
Suppose that you have a company that makes plastic syringes out of plastic A were to decide “Hey Plastic B is much cheaper lets use that instead”. Would the product classification change? Would there be a need for a PMA assuming this new Plastic B was never used before? Or could the company just classify it as a class 2 justifying that there are…[Read more]
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mah52 replied to the topic New Medical Device Project in the forum Introduction to Project Management 7 years, 2 months ago
I worked on a project to develop a needle that when used by the patient “Does not hurt as much”. That was the user requirement. So in order to asses what that meant or how to change that into product requirement the team sat with the medical affairs team and came to an agreement. Pain is associated with nerve simulation. Therefore the needle had…[Read more]
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mah52 became a registered member 7 years, 2 months ago
