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mmodi
@mmodi
Trusted Member
Joined: Jan 19, 2022
Last seen: Dec 3, 2022
Topics: 2 / Replies: 79
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RE: Class 2 device and 510(k)

To clarify from my original post, I would think as per the conditions listed by the FDA for what devices qualify as a Class 2 device and what prohibit...

3 years ago
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RE: Class 2 device and 510(k)

Thank you @wonbum-sohn for creating this post and for everyone who has responded. As mentioned in other threads, I am working on a point of care devic...

3 years ago
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RE: Regulatory Project Management

I have never worked in regulatory affairs, however, my understanding is that it is an essential segment of every industry, let alone the medical devic...

3 years ago
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RE: How do you deal with challenges?

It is interesting how everyone has reflected back on their days in senior capstone, which is a perfect example of a project - a temporary endeavor to ...

3 years ago
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RE: Projects and Programs

To answer this question, let's first define a program. A program is a group of related projects that are managed by a team as opposed to an individual...

3 years ago
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RE: Organizational Structure

Hello everyone! I know for week 1 we were only asked to read through chapter 1 of the PMBOK Guide and information on organizational structures is in c...

3 years ago
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