sandra-raju

Forum Replies Created

Confidentiality Agreements

In this week's lecture, Confidentiality Disclosure Agreements (CDA) and Non-Disclosure Agreements (NDA) were discussed as common agreements between companies. confidentiality agreements are necessary ...

In forum Consultants and Legal Basics

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

Personally I would always prefer a written agreement over an oral agreement because if disputes about different things come up later down the line, it is difficult to actually make a definite claim th...

In forum Consultants and Legal Basics

3 years ago
RE: Desicion made by one person

To expand upon what others were saying, communication is key to eliminating the possible disadvantage that comes with functional organization, but I want to highlight that this communication is more t...

In forum Organizational Development in Device Companies

3 years ago
Ghantt Chart vs. Network Diagram vs. Other?

In this week's lecture, we discussed what should be included in a design development plan, and two of the things suggested was a Ghantt Chart and a Network Diagram. What are the similarities and diffe...

In forum Organizational Development in Device Companies

3 years ago
RE: Project management

As previously mentioned, a design development plan is necessary to have the project run smoothly. Each of the components contribute to some aspect of the project to allow for all members of the team t...

In forum Organizational Development in Device Companies

3 years ago
RE: Risk analysis and moving forward with a project

I agree that safety should be the #1 think risk management and project teams should look into before pushing a product to market. If the medical device is not safe to use then there is no reason it sh...

In forum Risk Analysis for Medical Devices

3 years ago
RE: Risk Management Team =/= Project Team

Conflict of interest is the main factor as to why it wouldn't be ideal to have people who make up the risk management team also be on the project team. While having a member of the project team would ...

In forum Risk Analysis for Medical Devices

3 years ago
RE: Hazard, Hazardous, Harm

In any laboratory setting it is essential that individuals working there are wearing the proper clothing and personal protective equipment necessary with what they are doing. In the lab I work in, we ...

In forum Risk Analysis for Medical Devices

3 years ago
RE: Validation failure

Of course when a product or device fails a validation test, it can be frustrating to get it to start working again. However, as mentioned by others above, there are ways in which this process can be m...

In forum Introduction to Design Controls

3 years ago
RE: Gantt Chart Thought Process and Considerations

For my senior capstone, we utilized Microsoft Project Professional to make a Gantt chart to depict the timeline of our project. I believe the way a team should organize tasks in a Gantt chart should b...

In forum Introduction to Design Controls

3 years ago
RE: Minutes for meetings

I mainly had to write out minutes when I worked with a group for a project we were doing for our senior capstone. As people have mentioned before, meeting minutes are essential in the overall document...

In forum Introduction to Design Controls

3 years ago
RE: Minutes for meetings

While I was taking capstone/senior project my final year of undergrad, we needed to develop a new device from conception and planning, to actually building and testing it. Before this class, I would t...

In forum Introduction to Design Controls

3 years ago
RE: Design Controls

As mentioned in the earlier lectures by Dr. Simon, planning is a really important step in ensuring that the product being developed is comes out the best it can the first time around. If you do not th...

In forum Introduction to Design Controls

3 years ago
RE: Validation failure

As a validations engineer, if a product doesn't pass, I would first make a note of what aspect(s) of the product failed and report it immediately. It is important to report any failures immediately in...

In forum Introduction to Design Controls

3 years ago
RE: Placebo's Impact on Pain-related Clinical Research

The placebo effect is very interesting to me because just simply thinking that you are getting an effective medication could completely change how you feel, simply due to how our brains impact how mu...

In forum Clinical Research Basics

3 years ago
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