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quanzi
@quanzi
Eminent Member
Joined: Jul 1, 2020
Last seen: Aug 18, 2020
Topics: 6 / Replies: 19
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RE: Discussion Topic: Make a few, sell a few

Once the physician has an idea, they must determine which class their device falls into. The next concern would be the presentation of the idea to the...

5 years ago
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RE: Discussion Topic: Quality Assurance vs. Quality Control

Quality assurance is all of the processes established to ensure that a company is producing the best product to their customers. This process protects...

5 years ago
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RE: Discussion Topic: The cost of Quality

I believe it is important to protect your investments. It takes time and money to build a company. When dealing with medical devices, it can be an eve...

5 years ago
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RE: Discussion Topic: Brand new biomaterial

I am referring to the material having the desired interface with the tissue. Breast tissue is soft and fluid. A biomaterial acting as an implant must...

5 years ago
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RE: Discussion Topic: Brand new biomaterial

In order to test this new bio-material, I would perform testing based on the ISO 10993 international standard. This standard has 18 parts that evaluat...

5 years ago
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RE: Discussion Topic: Biomaterial Selection

It is important to be precise when selecting biomaterials for a device. They behave differently and have different interactions in the body. Some are ...

5 years ago
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RE: Discussion Topic: Beyond experimental design issues

The issues that can present in this situation can arise from the vast distance between the contracting company and the outsourcing company. The main i...

5 years ago
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RE: Discussion Topic: Project Management in a medical device setting

I believe the main challenge for project management for medical devices is that there are more strict regulations with the FDA. If a project is not ap...

5 years ago
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RE: Discussion Topic: Academia vs. Industry

For an argument in favor of academia, I would highlight that this job would be ideal if your career goal is to conduct research. Academia requires sig...

5 years ago
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RE: Discussion Topic: Covid19 and medical devices

COVID-19 has affected every area of life. The medical device development industry is no exception. Some changes have been delays to clinical trials an...

5 years ago
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