ag2265

Forum Replies Created

RE: Job Skills in Quality - Root Cause Analysis

When looking into Root Cause Analysis (RCA) I found that this type of analysis can be applied to a variety of industries and not just the BME sector. I found that there was an overall method that one ...

In forum Quality Control and Quality Assurance

3 years ago
RE: FDA Approval During Public Health Emergencies

I think one aspect that is important to note when discussing this topic is that although these vaccine companies were able to acquire EUAs, they still made the efforts of becoming FDA approved. The co...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: Does the FDA guarantee safety?

To answer your question of does the FDA guarantee safety - I don't think it is appropriate to look at this topic in absolutes simply because at the end of the day there will always be human error. Add...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: FDA vs EMA drug approval rate

I agree with what @AJY6 has to about the fact that the FDA is able to accomplish more at a faster rate than the EMA simply because they have over 10,000 employees working for them while the EMA has 89...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: Types of Research Models & Research Pitfalls

Hey @m_ridzon I like the questions you asked as I also had questions like yours prior working in research. I do not fully agree with @jadebowale said about what research models are when Professor Si...

In forum Pre-clinical Device Development

3 years ago
RE: Difference in Biocompatibility testing

Going off of what @Sandra-Raju said, other tests can include hemocompatibility, implantation, pharmacokinetics. Hemocompatibility looks into how blood reacts when interacting with the device. This is ...

In forum Pre-clinical Device Development

3 years ago
RE: Species in Animal Testing

After going through this thread I see that animals such as mice, rats, and primates have already been mentioned so I wanted to investigate other species. One animal model that the research lab that I ...

In forum Pre-clinical Device Development

3 years ago
RE: Benefits of an academia relationship

This topic of academic and student relationships really stuck out to me because I personally gained a priceless experience and relationship with my research mentor. Reading the replies made on this po...

In forum Introduction to Medical Device Development

3 years ago
RE: Week 1: Personal Growth and Development

Personal growth is a virtue that every individual should strive for regardless of their occupation, situation, or circumstance. From my personal experience I have seen personal growth in multiple form...

In forum Introduction to Medical Device Development

3 years ago
RE: Academia or Industry Preference?

Personally, I am a Master’s student who has no industry experience but approximately 2 years of research experience. I plan to complete my master’s and then work in R&D for a few years before retu...

In forum Introduction to Medical Device Development

3 years ago
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