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Forum Replies Created

RE: Punishment for Failing FDA Audits

Even though minor errors are present, it is still a mistake either way since it is, for example, a class III medical device. No one wants there to be an error once everything has been set in stone and...

In forum Regulatory Basics for Medical Devices

8 months ago
RE: Product Labeling

To me, there is someone that should be held accountable and responsible for the product mishap. I would choose not to buy that product. I agree with what vbp098 said. Most customers would notice the d...

In forum Regulatory Basics for Medical Devices

8 months ago
RE: Switching to a Regulatory Career

I would like to say that I am in the beginning phase of my career. I do not think I would switch from the engineering role to the regulatory role. Honestly I have not considered a more regulatory role...

In forum Regulatory Basics for Medical Devices

8 months ago
RE: Talking about animal research

Good communication is the obvious and most important step before anything for two parties in question rather than becoming physical when disagreements arise. It is not necessarily to come to a set agr...

In forum Pre-clinical Device Development

8 months ago
RE: Challenges in Applying ISO 10993 Standards

One of the common hurdles would be how much information there is available, as well as the accuracy of that said information. This mainly applies to principle eight being to consider all information f...

In forum Pre-clinical Device Development

8 months ago
RE: When researching, are you Academia or Industry?

Going back to Week 1, we have gone over the difference between academia and industry in terms of job opportunities, benefits, pros and cons, as well as what path each one of us wants to take. From whe...

In forum Pre-clinical Device Development

8 months ago
RE: Project Planning: How Much Detail is Enough?

I believe that too much detail is when the project is overflowing with information that is unnecessary. For example, a project has a central goal or the solidified scope that was established during th...

In forum Intro to Project Management

8 months ago
RE: Managing Team Opinions While Sticking to Decisions

This is a great question since this tends to happen a lot in the industry or during any project. This is why during the initiating, planning, and executing phases of the project, it is best and import...

In forum Intro to Project Management

8 months ago
RE: People in a Project

I believe that the connection within a team is extremely important to meet project goals and objectives at any job industry, not just biotechnology. Even though some people prefer to work alone on the...

In forum Intro to Project Management

8 months ago
RE: Thoughts on BS, MS, and PhD in BME

I do agree that having a BS is enough to employ you with a basic entry level position in engineering or in any other field in the industry. With four years of undergraduate study leading to a BS, this...

In forum Introduction to Medical Device Development

8 months ago
RE: Onsite or Remote (Work)

If I were to choose full-time remote versus being on-site, I would prefer working on-site. I only have experience at my current place of employment, but in an engineering position, I would still prefe...

In forum Introduction to Medical Device Development

8 months ago
RE: Academia or Industry Preference?

Ever since I have entered my undergraduate study, I have always been interested in working in the industry after graduation. I personally do not find the list of professions in academia to be what I w...

In forum Introduction to Medical Device Development

8 months ago
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