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hzy2
@hzy2
Eminent Member
Joined: Sep 9, 2018
Topics: 2 / Replies: 37
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RE: Restrictions for physician's gifts

I think it makes perfect sense that there are rules and laws that prevent these things from continuing to happen. As Dr. Simon mentioned in this week'...

5 years ago
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RE: NDA vs Patents

NDA is not a substitute for a patent. Patents give you a solid proof of ownership of an idea or a product itself whereas an NDA is just a contract tha...

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

This course was definitely beneficial in giving us an idea of what to expect when we go out into the real world. Dr. Simon did a good job in keeping u...

5 years ago
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RE: Upper vs Middle Management.

I agree with @jr377 that in order to move up to the upper level positions, you would have to be promoted from a middle level position. Similarly, in o...

5 years ago
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RE: Your Organizational prference; but why?

There are advantages to each type so it's good to go over those first before you make a decision to be part of one. From a project manager's standpoin...

5 years ago
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RE: Medical Device Project

We are planning on having weekly meetings to make sure everyone is on track. So far, we have completed the DID and DDP. Our project manager created a ...

5 years ago
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RE: Manage Risk

When developing a new product or device, there is always a risk that things might go wrong. In order to effectively deal with and overcome these risks...

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

Risk-benefit assessment is the foundation for FDA's decision making process in terms of its medical device regulations. This assessment helps to deter...

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

Medical device companies are required to have an established risk management process in compliance with ISO14971. This process includes identifying ha...

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

All of the design meetings held throughout the design and development stages were to ensure that the product design inputs met the product design outp...

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

I'm so glad that we have capstone as a required class. I think it would be really nice if we got to do a capstone project for each year that we are in...

5 years ago
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RE: Design Review Meetings

Design reviews are technical meetings held by a group of people who are working on the same project where the design for that particular project or pr...

5 years ago
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RE: Design input sources

Establishing solid design inputs are essential to the success of a project. Each and every single requirement to a product needs to be clearly stated ...

5 years ago
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RE: Factors to Consider While making Gantt Chart

Gantt chart allows you to create an outline of the tasks involved in a project and the time period in which those tasks need to be completed in order ...

5 years ago
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RE: What are Design Controls?

Design controls are necessary documentations required by the FDA to ensure that a product is in compliance with regulations, is safe and meets custome...

5 years ago
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