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cn249
@cn249
Trusted Member
Joined: Aug 29, 2025
Last seen: Apr 8, 2026
Topics: 0 / Replies: 63
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RE: Risk Responses

In the lecture, the risk management process involves assessing, evaluating, managing, and measuring. You assess the situation with what can go wrong a...

2 months ago
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RE: Initiating Process Group

During the lecture, Dr. Simon had explained and defined these three inputs that make up the initiating process group of PM. The Enterprise Environment...

2 months ago
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RE: Team members personal issues with eachother

A project manager chooses the people for a project team and that is part of the planning process group. They choose these people based on their skill ...

2 months ago
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RE: Failed Verification Testing

The only industry example I have is in a biotechnology company, but with medical device development, I have an example for when I worked on creating a...

2 months ago
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RE: Design Change Requests

The best way to avoid this type of situation is communication. Communication plays the biggest role in project management to relay messages or any sor...

2 months ago
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RE: Business and customer satisfaction in project management

Business needs and customer satisfaction should both be markers in the goals they want to accomplish in project management. For example, with running ...

2 months ago
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RE: Critical Role of Design Controls in Medical Device Projects

Like what many users have mentioned, involving regulatory experts and validation early into the development process is a way for organizations to find...

2 months ago
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RE: Should procedures or standards for verification and validation tests be approved by the FDA?

Verification checks that the inputs equals the output, meeting design specifications, while validation checks that the inputs equal the user needs or ...

2 months ago
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RE: Project Managers utilization of PDCA and other structured processes

If there are resource pressures or the lack of resources, during the planning stage, the project manager can identify what they need, what manufacture...

2 months ago
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RE: What are challenges will we face if we missclassify a medical device ?

According to the FDA, the classification of a medical device is based on finding the regulation number that is the classification regulation of the de...

2 months ago
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RE: The Role of Regulatory Strategy in Combination Product Development

As many users under this post have mentioned, a balance of both the medical device’s own regulatory experts and an outsource to consultants would be t...

2 months ago
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RE: Caution with Medical Devices that Require a PMA

To begin, PMA is one of the most rigorous applications out there for medical devices that can pose-high risk. This typically includes performing pre-c...

2 months ago
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RE: Works of a project manager and a program manager?

There are slight differences between the works of a project manager and program manager in terms of scope, change, planning, management, success, and ...

3 months ago
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RE: Remote or In-Person PM

Honestly at first, communicating in-person was the go-to method for companies, but it can be difficult to work fully in-person with a group of people ...

3 months ago
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RE: How to communicate effectively between team mates in project team ?

From many experiences with working in a project team as a member and as a leader, a lot of problems form due to miscommunication, misunderstanding, or...

3 months ago
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