sm2744

Forum Replies Created

RE: MBA/ Business degree for Engineers

Like mentioned above, we all pretty much agree that an MBA is not required to create your own business. To answer kaf43's question, I think that it is best for an engineer to gain industry experience ...

In forum Business 101

3 years ago
RE: Medical device startup: Partnership vs LLC vs S-Corp

I agree with the posts mentioned above that in founding medical device start-up, between a partnership or S-Corp, the S-Corp would be the way to go. However, I think that the best way to do this would...

In forum Business 101

3 years ago
RE: LLP’s responsibility

An LLP that I found was Scura, Wigfield, Heyer, Stevens & Cammarota, LLP in Wayne, Hoboken, Hackensack, Newark, and Secaucus in NJ. This LLP is made up of lawyers that specialize in bankruptcy and...

In forum Business 101

3 years ago
RE: Job Skills in Quality - Root Cause Analysis

I also do not work in industry yet and my experience is more relevant with creating and executing change notices. However, during my time as an intern doing so, I had to check all documents that refer...

In forum Quality Control and Quality Assurance

3 years ago
RE: QA/QC for a Medical Device Project

I think that a factor that is influenced by Quality Assurance is the continuous training employees undergo during their time with their department in the company. For example, at my past internship, w...

In forum Quality Control and Quality Assurance

3 years ago
RE: Switching to a Regulatory Career

I am not in Regulatory but I've toyed with the idea of moving into it for about a year, after I first heard about it. What attracts me is the opportunity for growth and the possibility of working more...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: FDA regulation example

I was looking at approvals that were granted this year looked further into these: CDRH - JUVÉDERM VOLUX XC, a gel implant/dermal filler. I've always heard of Juvederm in the media as a celebrity go-to...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: FDA Approval During Public Health Emergencies

I think there have been a few medical devices that have received EUAs, even during COVID. One example that I found was aimed at ventilator access as many hospitals found themselves not being able to s...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: Cutting Corners in Research

My opinion matches that of the majority. I do not believe that in research, corners should ever be cut. I completely understand why companies would do it. Time is money, and every day that a study goe...

In forum Pre-clinical Device Development

3 years ago
RE: Ethical Guidelines for Animal Use in Research

I think that an important guideline, as mentioned by others, is the "Responsibility for openness and sharing of data and material." This is important for both the scientific community as a whole but a...

In forum Pre-clinical Device Development

3 years ago
RE: Stability testing importance

I think another medical device that would be required to undergo stability testing would be wound dressings. The dressings need to be packaged in a sterile manner and must remain sterile until they ar...

In forum Pre-clinical Device Development

3 years ago
RE: PM certification benefits

I think obtaining a Project Management Certification will definitely help in "climbing the corporate ladder" and advancing in your career (maybe?) faster. As mentioned above, it can be obtained by bot...

In forum Intro to Project Management

3 years ago
RE: Project Planning: How Much Detail is Enough?

Similar to what the consensus seems to be, I also believe that the project planning phase needs to be as meticulous as possible but that it is also possible to go too in depth. An example that I'd ...

In forum Intro to Project Management

3 years ago
RE: Project Management Apps

I agree with both of you that Slack is a useful communication app and the having experience with Discord helps make using it more intuitive. I've recently discovered an app that I use for my personal ...

In forum Intro to Project Management

3 years ago
RE: Automated and Programmable Medical Devices ?

I agree with you that automated programs would make it so much easier to produce more sterile devices or in general, to help researchers create a more sterile field. This would allow researchers to wo...

In forum Introduction to Medical Device Development

3 years ago
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