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mk959
@mk959
Trusted Member
Joined: Jan 18, 2024
Last seen: Oct 1, 2024
Topics: 0 / Replies: 51
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RE: QA/QC Audits

To answer the overarching question: yes. Audits play a critical role in assessing whether QA and QC are following proper protocols. However, they are ...

3 days ago
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RE: Regulatory Compliance and Quality Assurance

Several key challenges are met when trying to ensure medical device safety and efficacy in the face of advancing technology and shifting regulations. ...

3 days ago
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RE: Quality To The Rescue

I agree with the points above about the importance of quality assurance and control in ensuring a product's safety and effectiveness throughout the pr...

3 days ago
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RE: Regulatory Department Functions

Both product development and post-market management are critically important to the regulatory process, but they impact projects in different ways. Pr...

2 weeks ago
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RE: Regulatory Classification of Internal Adhesives

The classification of an adhesive designed for interna use in medical devices on several factors, including the intended application, the materials us...

2 weeks ago
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RE: Responses to Public Health Emergencies

I think the way the FDA handled the COVID-19 vaccine rollout from 2020-2021 was a significant achievement, although it had its flaws. They were able t...

2 weeks ago
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RE: Balancing Medical Advancements and Ethical Concerns

During my undergraduate studies, I did research in a brain trauma lab where we primarily used mice and rats. For every test we wanted to run, whether ...

2 weeks ago
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RE: Regulations in Industry vs. Academia

Building on the points already mentioned, another key difference lies in the documentation and reporting requirements between industry and academic re...

2 weeks ago
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RE: Ensuring Biocompatibility in Medical Devices

Making sure a medical device is biocompatible for the duration of its lifecycle is crucial. This prevents adverse reactions such as inflammation or im...

2 weeks ago
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RE: PM cycle

Understanding the project management phases, every phase is necessary for the project to be complete thoroughly with a successful final project. That ...

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

From my experience both in a research lab and in industry, having "too much detail" depends on the task at hand. For instance, if I am running a roden...

3 weeks ago
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RE: Gantt Chart for Project Management

One lesson that I have learned from using Gantt charts to structure a project is leaving buffer time in as many places as possible. I would initially ...

3 weeks ago
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RE: The Advantages and Disadvantages of Being Overqualified

There are two ways to look at this question - from the viewpoint of the employer and the employee. The employer may like an overqualified employee a...

4 weeks ago
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RE: Grades and GPA's in graduate education

I mostly agree with the arguments that grades and GPAs are not important in industry, but at certain times in an individual's career or in certain fie...

4 weeks ago
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RE: Academia or Industry Preference?

When deciding between academia and industry, both the financial compensation and the long-term benefits need to be reviewed. Industry will give a sign...

4 weeks ago
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