mme54

Forum Replies Created

RE: Discussion Topic: The cost of Quality

I think I agree with that the QA/QC department seems to be a burden.I think that because during the training of the SOPs in the manufacturing process as well as in the QC department, the scientists or...

In forum Quality Control and Quality Assurance

2 years ago
RE: Discussion Topic: Quality Assurance vs. Quality Control

From my understanding QC and QA are very different but they kinda have the same function as during my working as QC/QA intern at pharma company and manufacturing associate at another one . I was doing...

In forum Quality Control and Quality Assurance

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

I believe that the antibiotic-releasing hip stem is combination object that should be classified as a Class III medical device, considering that implants generally fall into this category due to their...

In forum Regulatory Basics for Medical Devices

2 years ago
RE: Approaches to Research

I believe that the two approaches to research, academia and industry, each have their own merits and drawbacks. In academia, research tends to be more fundamental and exploratory, focused on advancing...

In forum Pre-clinical Device Development

2 years ago
RE: Milestones Missed: Failure or Success?

As a student, I've learned that whether missing a project milestone is seen as a failure or a success in terms of improving the overall project depends on several critical factors. First and foremost,...

In forum Intro to Project Management

2 years ago
RE: PM certification benefits

As a student, it's evident that project management serves as the cornerstone for achieving successful outcomes. To bolster my prospects as a future project manager, I've learned about several valuable...

In forum Intro to Project Management

2 years ago
RE: PM stakeholders benefits

As a student, I've come to understand that the stakeholder who would be most affected by the abundant success of a project is unquestionably the project sponsor. This person or organization provides t...

In forum Intro to Project Management

2 years ago
RE: The Advantages and Disadvantages of Being Overqualified

Academically speaking, I would prefer to be overqualified for my job. In the short term, this would likely lead to a smoother and more confident start in the position, as I would possess the necessary...

In forum Introduction to Medical Device Development

2 years ago
RE: Benefits of an academia relationship

As a student, I can definitely attest to the immense impact of having a positive and supportive relationship with a teacher. When I feel that my teacher genuinely cares about my progress and well-bein...

In forum Introduction to Medical Device Development

2 years ago
RE: Improvements in Telehealth through Medical Devices

I personally believe that the transition to digital healthcare has significantly increased healthcare accessibility, especially in response to the COVID-19 pandemic. Before the pandemic, many individu...

In forum Introduction to Medical Device Development

2 years ago
RE: Does the FDA guarantee safety?

I used to think that FDA-approved drugs were completely safe, but after seeing the endless lists of side effects in drug commercials and hearing about FDA-approved drugs that were later recalled, I'm ...

In forum Regulatory Basics for Medical Devices

2 years ago
RE: Discussion Topic: e-cigarettes

Yes, the FDA does currently regulate e-cigarettes as tobacco products. This means that e-cigarette manufacturers must adhere to specific regulations, including restrictions on sales to minors, and the...

In forum Regulatory Basics for Medical Devices

2 years ago
RE: Switching to a Regulatory Career

I come from an engineering background, and the idea of transitioning to a regulatory role did cross my mind. What attracted me to this possibility were the broader perspectives it could offer. As an e...

In forum Regulatory Basics for Medical Devices

2 years ago
RE: Animals used for research and for food

I've often pondered this ethical dilemma regarding animal research versus the consumption of animals for food. It's a complex issue, and I believe there are a few key factors that contribute to the di...

In forum Pre-clinical Device Development

2 years ago
RE: Animal Diversity in Pre-clinical Research

Animal diversity can have a significant impact on the reproducibility of preclinical research, and I've seen this firsthand in my work. When we conduct preclinical trials using a single lab creature, ...

In forum Pre-clinical Device Development

2 years ago
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