hmara

Forum Replies Created

RE: Discussion Topic: Inc. vs. LLC in the US

I would say that a company like the one described in the prompt would qualify as a Corporation rather than an LLC. A med device company would tend to want longevity and stability, which a corporation ...

In forum Business 101

3 years ago
RE: Quality Assurance Job Example

I agree with both posts above, while I don't have specific BME industry experience. In my personal exposure to industry (Telecom), clients are often removed by one degree. The large companies will int...

In forum Quality Control and Quality Assurance

3 years ago
RE: What are some ways Document Control can improve?

Document control is paramount in any project, traceability is one of the core principles of quality. As documentation is so prevalent and deeply ingrained in everything we do during a project, streaml...

In forum Quality Control and Quality Assurance

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

Last year I developed a medical device for BME capstone at NJIT. Based on what we've learned this last week in Dr. Simon's lectures; I would say that the management body (In our case the professor/cus...

In forum Quality Control and Quality Assurance

3 years ago
RE: Discussion Topic: Antibiotic-Releasing Hip Stem

An antibiotic releasing hip stem is an orthotic implant with a novel coating that fights osteomyelitis. This would fall under the CDRH sub-organization, and would need to pass premarket approval. It w...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: FDA Transparency

I like this question as it asks us to regulate the regulators. In this charged media atmosphere with misinformation running rampant; important data about regulated items that may affect the health of ...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: The people we shall encounter in the field

In my experience working at an engineering firm this last year, I absolutely think a diverse background is important for a successful workplace. Every single employee has a different mind and viewpoin...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: Academia or Industry

This is a question I have been grappling with for the few months after my undergrad. After reading the other responses here it seems I agree most with the last two responders @nm523 & srp98. It wo...

In forum Pre-clinical Device Development

3 years ago
RE: Stability testing importance

An extremely important device that should be stability tested is the IV needle. These needles vary in gauge and application depending on user age and vessel availability. As such, there are many facto...

In forum Pre-clinical Device Development

3 years ago
RE: Funding in Academia Vs Industry

All in all, not finishing research is a detriment to all involved. If said research was well planned, well executed, and presented an opportunity to advance humanities scientific knowledge; the resear...

In forum Pre-clinical Device Development

3 years ago
RE: Project Management: Scope Statement

The most important thing when defining project scope is budget. The amount of capital a project team has access to directly impacts all processes of said project. Do we have the money to hire consulta...

In forum Intro to Project Management

3 years ago
RE: Project Management Apps

I have used slack on multiple occasions for different organizations. I do agree that its similarity to Discord and other IM apps allows for swift communication between group members. Info can be disse...

In forum Intro to Project Management

3 years ago
RE: Which feature is the most important for a project manager?

In my experience at my industry position, communication is the number one quality a good project manager should have. A project cannot begin without the initiation phase; who's entirety is managed by ...

In forum Intro to Project Management

3 years ago
RE: Work hours determined by project or set schedule?

I think this topic is very relevant now; we've all read the stories about "quiet-quitting" and how workplace dynamics have changed post-covid. However, most of these come from corporate offices with r...

In forum Introduction to Medical Device Development

3 years ago
RE: Biomedical Engineers vs. Mechanical Engineers: Who has the advantage in Biomechanics?

From my experience in the job search for the past 6 months, mechanical engineers definitely have an advantage over biomedical engineers. At the bachelors level strictly; once a BME specializes their s...

In forum Introduction to Medical Device Development

3 years ago
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