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amandaally1029
@amandaally1029
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Joined: Sep 6, 2017
Topics: 8 / Replies: 32
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RE: Written Agreement v/s Verbal Agreement

There is definitely a difference between verbal agreement and written agreement. Verbal agreements don't seem very solid, and can be manipulated if t...

7 years ago
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RE: Restrictions for physician's gifts

I agree with the fact that if there is a business deal between two people, it shouldn't involve other family members. Therefore, I don't think that t...

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

Dr. Simon, I learned a lot from this course, and I think I have a better outlook on what to expect in terms of going into the industry. I haven't had...

7 years ago
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RE: Collaboration projects

I also agree with Adrian. If there is a set up for a collaboration, the organizational structure shouldn't matter, but more so that the companies are...

7 years ago
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RE: Forming a Project Team

I think its best to work with people who are more knowledgeable in their area, than with people you are close to. I think its a bad idea to work with...

7 years ago
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RE: Discussion Topic: Your organizational type

I do not currently work in an organization, but if I had to pick the type it would be a matrix organization. I like that with this type of organizati...

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

First, I'd want to make sure that everyone in the project understands what the device is, its purpose, its design, and how it will be processed. Once...

7 years ago
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RE: What is Risk-benefit analysis ?

one factor to consider is the assessment of the risks of the device. With this assessment you can determine the severity and number of harmful events...

7 years ago
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RE: Discussion Topic: Risk Management, Risk Analysis

Risk Management is required by the ISO 14971, and must be completed by the company. The company will go through the cycle of assessing, evaluating, m...

7 years ago
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RE: a successful validation process

I think a successful validation process involves repetition and numerous trials of testing. I haven't had experience in the industry with medical dev...

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

Everyone raised some good points regarding verification and its importance. Verification is indeed an essential process in design control, and it can...

7 years ago
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RE: Customer Needs, Business Requirements, Test Plan

I also had to complete Requirement Documents and Test Plans for my capstone senior project. I agree that it does take a lot of time to complete becau...

7 years ago
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RE: What FDA Looks For In A Design Control System ?

I'd also like to add on the importance of risk analysis for a Design Control System. Overall, everything boils down to the well-being of the people, ...

7 years ago
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RE: How to ensure your DHF is audit ready ?

I also agree, the DHF documents should always be updated throughout the project. I have not had experience dealing with DHF files but based on what I...

7 years ago
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