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alexandrabuga replied to the topic "Categorization of Medical Devices" – 5 years, 11 months ago
@f-dot, I agree that the FDA does have to stay on top of modern day devices applications, but don’t think modern day technologies need a different classification system. I think it is still useful to a classification system based on… Read more»
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alexandrabuga replied to the topic "Your Ideas about How to prepare/write a Successful Project Proposal" – 5 years, 11 months ago
I agree with @iala4 that important sections to include are 1. Background 2. Objective 3. Scope 4. Time frame 5. Project budget 6.Key stakeholder. I also agree with @f-dot that a realistic budget and timeline are key. With the projects… Read more»
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alexandrabuga replied to the topic Categorization of Medical Devices in the forum Introduction to Project Management 6 years, 11 months ago
@f-dot, I agree that the FDA does have to stay on top of modern day devices applications, but don’t think modern day technologies need a different classification system. I think it is still useful to a classification system based on risk, Class I, Class II, and Class III devices. I think they could maybe include more guidance documents regarding…[Read more]
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alexandrabuga replied to the topic Your Ideas about How to prepare/write a Successful Project Proposal in the forum Introduction to Project Management 7 years, 2 months ago
I agree with @iala4 that important sections to include are 1. Background 2. Objective 3. Scope 4. Time frame 5. Project budget 6.Key stakeholder. I also agree with @f-dot that a realistic budget and timeline are key. With the projects that I deal with if we contract out the development we look for the company to provide an extensive timeline with…[Read more]
