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Forum Replies Created

RE: Significant or non-significant risk

Hello Roberto, This is a really interesting point. I had that question come up to my mind as I was watching the lecture. With some research I found a clear answer to that concern on the FDA website. A...

In forum Introduction to Project Management

8 years ago
RE: Mobile Medical Applications

I agree with my classmates that your application that you designed for senior project should be classified as a mobile medical app. I couldn't access your reference link, but I found two links by the ...

In forum Introduction to Project Management

8 years ago
RE: Project Manager Skills

I believe that a good skill that a project manager should have is giving other team members the spirit of acting as team players in the role of project management. They should have the limited freedom...

In forum Introduction to Project Management

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

I have read opinions from other classmates and I agree and disagree with each one of them at different points. I agree that project management basics of being a good leader and other similar skills ar...

In forum Introduction to Project Management

8 years ago
RE: Discussion Topic: State of your Organization

I don't have any experience in the industry yet. However, I feel like a matrix type organizations is more appealing to me. I feel it like it promotes challenge and creativity. Matrix organizations hav...

In forum Introduction to Project Management

8 years ago
RE: Written Agreement v/s Verbal Agreement

I agree with everyone who mentioned the importance of a written agreement, and I agree with your point Roberto. The only part I would like to comment on is about the condition you set for verbal agree...

In forum Consultants and Legal Basics

8 years ago
RE: Restrictions for physician's gifts

Hello Roberto, Very interesting topic. Although the example you mentioned might be humanely absurd, but I agree with my classmates. The restrictions are highly important. I come from a country where ...

In forum Consultants and Legal Basics

8 years ago
RE: Discussion Topic: Course conclusion and impressions

When I signed up for this course, I was expecting, as others have mentioned, more of a theory content about medical devices. When I looked at the syllabus and attended the first meeting, I was even mo...

In forum Consultants and Legal Basics

8 years ago
Project Management Preferences

The lectures introduce the three types of organizations. Project managers' roles are specifically mentioned in both matrix and project-based organizations. While other posts discussed the preference o...

In forum Organizational Development in Device Companies

8 years ago
RE: Organization types of medical devices?

I agree with you that this type of organization is good for a start up. on the other hand, as the company grows overall I would prefer to have a company that operates in the matrix way. It promotes in...

In forum Organizational Development in Device Companies

8 years ago
RE: Discussion Topic: Your organizational type

I would like to work for a matrix type organization. Matrix type seem flexible to the changes in its environment. Those types of organizations can shift focuses and resources toward major problems and...

In forum Organizational Development in Device Companies

8 years ago
The change from ALARP to AFAP

While researching about one of the discussions posted on the forum about "As far as possible (AFAP)", I came across the fact that they have changed to this term from " As low as reasonably practicable...

In forum Risk Analysis for Medical Devices

8 years ago
RE: Usability Risk Analysis

Hi, I agree with Irene on using quantitative methods. I found a good research paper on using this method in medical devices. The research says that the method is widely used in pharmaceuticals but it ...

In forum Risk Analysis for Medical Devices

8 years ago
RE: Risk Management Mistakes

Thank you for sharing this! I agree with you. It is a very interesting read. I was researching more on the topic and found another link that lists possible ways on using risk management efficiently an...

In forum Risk Analysis for Medical Devices

8 years ago
RE: Making up tests for design verification and validation

Hello Roberto, I have done some research like my classmates, it was interesting to read that the FDA points out to verification not only in terms of tests. They list guidelines such as analysis and in...

In forum Introduction to Design Controls

8 years ago
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