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AJY6
@ajy6
Estimable Member
Joined: Jan 22, 2022
Last seen: Nov 28, 2022
Topics: 26 / Replies: 56
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RE: Discussion Topic: Course conclusion and impressions

So far, I've taken two of Dr. Simon's courses, and I enjoyed them because they allowed me to get a glimpse of the real world and see how things work i...

1 year ago
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RE: Written Agreement v/s Verbal Agreement

If only two people are present while making the verbal agreement, then it will not be sufficient. Three other people should be present while creating ...

1 year ago
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Replies: 5
Views: 270
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RE: Forming a Project Team

I believe working with someone more knowledgeable in the specific role is better because experience is everything when just getting started. For examp...

1 year ago
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RE: Project management

The design development plan should include the budget, a product design schedule, and tasks that must be completed. Without these three main component...

1 year ago
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RE: Desicion made by one person

In a functional organization, if the decision is made only by one person, then something has gone wrong somewhere. This is because usually when you ma...

1 year ago
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RE: Risk Management Team =/= Project Team

This can affect both teams positively or negatively, but there are different scenarios. For example, if the risk management team is having a hard time...

2 years ago
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RE: Benefits of post-market surveillance

Post-market surveillance is needed for all medical devices after they are on the market. So post market is essential because it will tell you how the ...

2 years ago
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RE: Dealing with risk

This is a great question; it should never be okay to accept the risk of something that may affect someone's life. However, there is always risk in the...

2 years ago
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RE: Design Controls

To ensure a product is always high quality, one should make checkpoints between the manufacturing stages of the device to see if everything is up to s...

2 years ago
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RE: Customer Needs and Design Input

The Design Specification Document (DSD) gives the numerical details of the product and explains every individual piece with the size and tolerance. Th...

2 years ago
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RE: Design Verification vs. Validation

Design verification is in the check phase, so this is where one makes sure the outputs equal the inputs. One way to ensure the verification phase is c...

2 years ago
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RE: Design Controls: What do you deem most important?

I believe the design history file (DHF) of the nine design controls is the most important because it contains all the documents for the whole project....

2 years ago
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2 years ago
Replies: 7
Views: 351
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