asimbana

Forum Replies Created

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

I agree with @bb254, if a mid-sized company is making $10 million in revenue per year, the company would generate a larger net worth if the company became an Inc corporation. As discussed in the previ...

In forum Business 101

8 years ago
RE: Issues with the Quality Department

Based on my work experience with the current company i am with, i have worked with both Quality engineers and R&D engineers/scientists. The common problem i have seen is that projects in fact due ...

In forum Quality Control and Quality Assurance

8 years ago
RE: R&D vs Quality

In industry, there will always be a situation where departments will not be in the same page and this is because they have different objectives. In this case where the production of a new medical devi...

In forum Quality Control and Quality Assurance

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

QA/QC is the integral part of any medical device or any product in general. The department is practically a checks and balances for the product to ensure it meets it's intention without any defects. I...

In forum Quality Control and Quality Assurance

8 years ago
RE: Discussion Topic: Revamping the 510(k) Process

Throughout the years lawmakers and government departments such as the FDA have modified and added regulations to ensure that it tackles on all possible issues and meets their mission statement while m...

In forum Regulatory Basics for Medical Devices

8 years ago
RE: Discussion Topic: e-cigarettes

The FDA regulates the e-cigarette as stated earlier in the previous posts, this is because its a device that uses chemicals that is heated into a vapor and delivers to the human body via the lungs. Th...

In forum Regulatory Basics for Medical Devices

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

In regards to the antibiotic-releasing hip-stem implant this medical device would be considered a combination device since the product has two functionalities; however the overall primary mode of acti...

In forum Regulatory Basics for Medical Devices

8 years ago
RE: Approaches to Research

The beauty of research is that even in academia or industry, it speaks the same general language and can be translated between both worlds. However, the goal is where research changes direction. In ac...

In forum Pre-clinical Device Development

8 years ago
RE: Discussion Topic: Brand new biomaterial

Before biomaterials can be used for testing during clinical trials, the product must undergo specific testing verification such as using the toxicity table to ensure that the product checks off requir...

In forum Pre-clinical Device Development

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

Animal testing procedures can encounter many pitfalls in the course of it's phase just as many other testing procedures such as clinical trials. Considering in this scenario that the company is using ...

In forum Pre-clinical Device Development

8 years ago
RE: Project Life Cycle

I believe that in a project's life cycle, all subsections are essential when it comes to a product's development. When it comes to medical device development, the cycle is broken down into numerous of...

In forum Intro to Project Management

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

The difference between being a project manager for a medical device project compared to a building/construction project is that in the medical device industry, the project manager must see the project...

In forum Intro to Project Management

8 years ago
RE: Obstacles while working on a project

An obstacle that I've encountered when working on a project would be unexpected delays and time management when it comes to working with a team. A saying I always keep in mind when working on projects...

In forum Intro to Project Management

8 years ago
RE: Discussion Topic: Practical vs. Informational courses

From what I have visualized, I have noticed that for some engineers they can have a great foundation in theory instead of the practical aspect of their given major. This can play a major role in obtai...

In forum Introduction to Medical Device Development

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

Academia and Industry careers have their pros and cons which become more prominent based on what type of individual you are. In my case, I have undergone some Academia work experience (NJIT Research r...

In forum Introduction to Medical Device Development

8 years ago
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