dh239

Forum Replies Created

RE: Restrictions for physician's gifts

I feel that the rules are necessary. While it is nice to thank a collaborator and talk business over a dinner or conclude a deal with a gift, it is influencing the other party in a way that has nothin...

In forum Consultants and Legal Basics

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

Initially, I imagined this course would be about the considerations put into each medical device and the creation of devices and was not expecting a course on the industry itself. However, the course ...

In forum Consultants and Legal Basics

7 years ago
RE: NDA vs Patents

An NDA seems to be a precursor to a patent where a developing idea can be reserved and kept secret while it is developed into an idea that is capable of being patented. NDAs cannot substitute a patent...

In forum Consultants and Legal Basics

7 years ago
RE: Collaboration projects

I agree with the previous post: matrix organizations are definitely better suited for collaboration projects. They are more efficient and would save resources and allow for a more seamless flow betwee...

In forum Organizational Development in Device Companies

7 years ago
RE: Forming a Project Team

I definitely think that there should be a balance between team relationship and expertise. It is possible to develop a good team dynamic from random individuals so long as there is proper leadership, ...

In forum Organizational Development in Device Companies

7 years ago
RE: Upper vs Middle Management.

I also see myself to be better suited for a middle management role. I have limited experience and would not be suited for an upper management position which would require expertise on a more global le...

In forum Organizational Development in Device Companies

7 years ago
RE: How to run a risk management meeting ?

As others have mentioned, a thorough understanding and full participation from all members is crucial for a risk management meeting. In order to ensure unique thought and involvement, I feel that it w...

In forum Risk Analysis for Medical Devices

7 years ago
RE: Usability Risk Analysis

I believe that thorough documentation of failures and tests with attention to a variety of components would be the best way to analyze risk. Often times, failures due to one cause can indicate weaknes...

In forum Risk Analysis for Medical Devices

7 years ago
RE: how far is "As Far As Possible"

"As Far As Possible" (AFAP) sounds like a very general term that is open to interpretation and so it becomes the work of the company to meet industry standards for risk assessment and minimalization. ...

In forum Risk Analysis for Medical Devices

7 years ago
RE: Design Review Meetings

During a design review, at least within the bounds of our senior project, we would evaluate our project step by step with our customer and group members. Usually, during this time, problems were point...

In forum Introduction to Design Controls

7 years ago
RE: Why VERIFICATION is important? and Your ideas to improve Verification process ?

Early verification and a thorough verification are both necessary to ensure that no problems arise in the future. I agree that the cost to compensate for a mistake far exceeds that of taking preventat...

In forum Introduction to Design Controls

7 years ago
RE: Design Transfer

While I agree that outsourcing can be a cost-effective and overall wise move for a company, there are also a few drawbacks to consider. Primarily, outsourcing adds another step to bringing the product...

In forum Introduction to Design Controls

7 years ago
RE: When is validation is not required?

Validation is not necessary when there is an update to the design which has no bearing on the usability or function of the product. For example, changing the color of a device from blue to green, wher...

In forum Introduction to Design Controls

7 years ago
RE: Design Verification & Validation

Design verification deals with confirming the inputs of the project with its outputs. It is a way to see that the requirements have been met and that the device was created in its entirety. Validation...

In forum Introduction to Design Controls

7 years ago
RE: Minutes for meetings

In our student organizations, minutes were always a chore delegated to the lowest ranking member. However, last year it became an issue when our minutes were not posted on the website. We were finaliz...

In forum Introduction to Design Controls

7 years ago
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