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ak977
@ak977
Eminent Member
Joined: Jan 16, 2018
Topics: 3 / Replies: 38
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RE: Your Ideas about How to prepare/write a Successful Project Proposal

As you guys have mentioned, the project proposal is the heart of the initial project. It is meant to be a short, insightful look into what the device ...

7 years ago
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RE: Validation and Verification

I think that the process of V&V, with the many years of re-evaluating, has become a lot more streamlined than it was previously. Although it can b...

7 years ago
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RE: Validation and Verification

I think that the process of V& V, with the many years of re-evaluating, has become a lot more streamlined than it was previously. Although it can ...

7 years ago
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RE: ''Quality Plan'' meaning ?

I agree with krp67 -- the question of why is very important when it comes to any sort of development. Why is something being created? Why must it go t...

7 years ago
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RE: Stakeholders in Medical Device development

It makes sense that the customers for medical device companies would be hospitals/doctors and not actual patients. Companies need to sell their produc...

7 years ago
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RE: Challenges in the Global Regulatory Environment

Reply to: ap962 Its interesting that the FDA is so much more stringent with medical devices in comparison with other countries. However, there are asp...

7 years ago
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RE: FDA Approves First Digital Pill in USA

I agree with wms7 -- the pill's primary function is to cause changes in the body biologically and therefore, it would be assigned to the CDER. The sen...

7 years ago
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RE: Discussion Topic: Projects of all types

The ideal version of a project manager would allow the person to be able to work across the board of industries, regardless of their technical knowled...

7 years ago
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RE: Discussion Topic: Share your project management experience

At my previous jobs, which were not in the medical device industry, the lines of communication were relatively open but not always utilised to the ful...

7 years ago
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RE: Decision Making: To do or Not to Do?

If there were more coatings then there might be more options to what the clear choice may have been. Perhaps coating C could have garnered quicker res...

7 years ago
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RE: Interpersonal skills vs technical knowledge

I agree with smk45 -- technical skills, for a student, are a bit more important than they are for the average professional. As a student, its hard to ...

7 years ago
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