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Forum Replies Created

RE: Discussion Topic: Design and Process Verification

I believe that verification should take place during the Execution phase of the project, but it does not necessarily need to be a rigid rule. As seen in the first simulation, there were gaps in the ve...

In forum Project Management Process and Medical Device Development

4 years ago
RE: Missing a Milestone Experience

I have had a specific work experience where a my team was assigned to completed an investigation write-up for a CAPA. The day it was due, our boss had reviewed it and decided the investigation did not...

In forum Project Management Process and Medical Device Development

4 years ago
RE: Estimating Project Timeline

When creating a timeline for a project, using timelines of similar tasks may aid in estimating a timeline for a project. However, one thing that I have seen that helps with timelines is having weekly ...

In forum Project Management Process and Medical Device Development

4 years ago
RE: Assessing & Evaluating Risks of a Medical Device

Having worked in the complaints department, we work with risk documents very frequently. Risk management data used in the risk management documents are compiled from historical complaints data as well...

In forum Project Management Process and Medical Device Development

4 years ago
RE: PM: Handling Team Issues

From seeing how well my boss handled my team as a supervisor, especially during the COVID-19 Pandemic, there were a few key lessons I have learned that I would like to apply to when I become a project...

In forum Project Management Process and Medical Device Development

4 years ago
RE: Risk Management impact

Having worked in Quality, risk is very important when it comes to projects and product development. It is what runs companies and allows them to continue developing products. From my experience workin...

In forum Project Management Process and Medical Device Development

4 years ago
RE: Experience with Project Organizations

The team I work on currently is a functional organization type. My department is very efficient when it comes to completing projects needed from our department. Communication is excellent across all i...

In forum Introduction to Project Management

4 years ago
RE: Determining project priority

When I was scrolling through the prior posts, I agreed that certain projects should not be cancelled and that they may be given lower priority if another project can maximize the company’s profit. How...

In forum Introduction to Project Management

4 years ago
RE: Pros and Cons of the 3 Organizational Structures

Each type of organization has their pros and cons, and largely depends on the company and its goals. For a company that provides products/solutions for specific clientele, a project-based or matrix or...

In forum Introduction to Project Management

4 years ago
RE: Safety Recalls

Posted by: @as934 My question is whether a recall would need to be submitted for issues involving missing information or label errors, even if there is no issue with the product itself. If the labels...

In forum Introduction to Project Management

4 years ago
RE: Project Manager Skills

From my experience working in a professional environment, and from my senior design course, one skill that I believe is essential for a project manager in order to succeed is organization. With organi...

In forum Introduction to Project Management

4 years ago
RE: Global Teams disrupted by Catastrophe

If faced with such a crisis where my company’s manufacturing sites can not meet the demands of what the company requires, manufacturing of products would definitely see a decrease. From a supply and d...

In forum Introduction to Project Management

4 years ago
RE: 510(k) clearance vs. Postmarket Approval

Like many of my classmates have mentioned, no company should have to consider “embellishing a new device” in order to complete a 510(k) rather than a full-on PMA, it can be representative of how serio...

In forum Introduction to Project Management

4 years ago
RE: Project Approval

@jafar I agree with the key points you mentioned regarding how to identify your target market when proposing a project you wish to launch. From my experience in working in a medical device company, we...

In forum Introduction to Project Management

4 years ago
RE: Covid-19 Disruption to Project Management

Working in a corporate environment, I feel that having the face-to-face interaction is definitely helpful, but not necessary. We have been able to navigate through the pandemic without the need to see...

In forum Introduction to Project Management

4 years ago
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