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EJ851996
@ej851996
Trusted Member
Joined: Sep 12, 2022
Last seen: Apr 30, 2023
Topics: 1 / Replies: 77
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RE: Cost/benefit for risk management

I believe modifying the risk part is the most efficient method for cost down. However, it is impossible to create a device without any risk. Some func...

2 years ago
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RE: Benefits of post-market surveillance

Post-market surveillance is essential for the most medical device. A company needs to track the performance of its product. It can extend the product'...

2 years ago
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RE: Hazard, Hazardous, Harm

The most impressive hazard event for me was the cadmium poison pollution in Toyama prefecture in Japan in 1912. I still remember this event because ca...

2 years ago
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RE: Design Verification & Validation

It confused me at first, but I figured out the difference by remembering the different results of Validation and Verification want. Verification is a ...

2 years ago
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RE: Minutes for meetings

I believe the meeting recording is essential. I used to attend a meeting that several research teams needed to report to the head of research and deve...

2 years ago
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RE: Design "Overvalidation"?

When a company is preparing the project definition form, the market department should already conclude the requirement of the customer and engineering...

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

Every component of design control is significant, and each one relates to others. I believe opinion input and verification are the most important of t...

2 years ago
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RE: Design Verification Ethics

I don't know or hear of any company that does such things. It's illegal and unethical behavior for a company. The skipping and instead the data would ...

2 years ago
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RE: Customer Needs and Design Input

Both documents are necessary for the project design because they are the basic description for different readers. The advantage of DID document is tha...

2 years ago
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RE: Clinical Studies

I believe the clinical trial is significant for the new device and drug development. Although everything that comes to the clinical trial has the IDE ...

2 years ago
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RE: Clinical Trial Roles

I want to be a clinical investigator if I attend a clinical trial. An investigator must contact the patient, enroll the subject, set up the following ...

2 years ago
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RE: Incentives for Clinical Trial Participants

Some patients might accept a clinical trial because this therapy might be a new option for their disease. It might also be because monetary compensati...

2 years ago
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RE: Transition from Engineering to sales or marketing?

I prefer marketing over sales if I want to change my career route from engineering to these two areas. Being a sale is more complex than I thought. Sa...

2 years ago
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RE: Qualifications of Sales People

I agree that medical sales should have basic knowledge about their products. But nobody knows everything they sell in the company. So I believe that t...

2 years ago
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RE: Advertising

The most impressive advertisement for me is the GEICO car insurance ad. Their mascot is the most iconic symbol for their company. They usually use thi...

2 years ago
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