vthampi

Forum Replies Created

RE: A day in the life working in QA/QC

I have worked as a risk management intern for a medical device company and have spoken with a lot of team members who have worked in risk management for years. I would say that their day-to-day tasks ...

In forum Quality Control and Quality Assurance

2 years ago
RE: Experience in Quality Assurance and Quality Control

I worked as a quality assurance engineering intern in a medical device company this past summer. One of my projects involved the review of tests conducted to prove a particular device's compliance to ...

In forum Quality Control and Quality Assurance

2 years ago
RE: Items Affecting Quality

I worked as a risk management intern (Quality Assurance) in a medical device company and I can say with confidence that one of the most important things to consider while maintaining a quality managem...

In forum Quality Control and Quality Assurance

2 years ago
RE: Measurement System Analyses During Testing Pre-Approval

I agree with the previous commentor: MSA is critical to making sure that you are providing exactly what you said you would. Without MSA, there would be no consistent or reproducible data to show that ...

In forum Regulatory Basics for Medical Devices

2 years ago
RE: FDA Transparency

I agree with most of the commentors here saying that a company needs to be 100% transparent with the FDA. It's for the safety and efficacy of the device coming to the market and it is 100% necessary t...

In forum Regulatory Basics for Medical Devices

2 years ago
RE: Responses to Public Health Emergencies

Although not entirely ideal, I believe the FDA handled the vaccine rollout in the best way they could. A big component of getting people vaccinated was fighting against misinformation, which is always...

In forum Regulatory Basics for Medical Devices

2 years ago
RE: The Five Phases of Medical Device Development

The development of a medical device is a project, so it would benefit from project management-related tools such as Gantt charts and WBSs. Especially in an industrial setting, planning in advance with...

In forum Pre-clinical Device Development

2 years ago
RE: Difference in Biocompatibility testing

Some interesting biocompatibility tests I found are sensitization assays, irritation tests, and subchronic toxicity testing. Sensitization assays are tests done to show any adverse effects a certain m...

In forum Pre-clinical Device Development

2 years ago
RE: When researching, are you Academia or Industry?

Academia research would absolutely more enjoyable for the sake of research. Being on the threshold of human knowledge and being able to take and sit on as many projects as you like is very appealing. ...

In forum Pre-clinical Device Development

2 years ago
RE: PM cycle

It's difficult to determine the relative importance of the steps of the project lifecycle because they are all necessary to complete a project. It's similar to looking at a perfectly functional four-l...

In forum Intro to Project Management

2 years ago
RE: Project Management Drives Changes

I think to a certain degree, project managers need to be comfortable with interacting with people. If someone has severe communication issues or social anxiety, they might not thrive in project manage...

In forum Intro to Project Management

2 years ago
RE: Project Management Strategies in Academia

When examining the differences between industry and academia, the one thing that jumps out the most is the end goal of each. In academia, you're working to advance the field. The goal is ambiguous. Yo...

In forum Intro to Project Management

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

Having fixed hours versus working to complete one's work both have pros and cons and is likely going to depend on not only each person's preference, but their manager's management style as well. Havin...

In forum Introduction to Medical Device Development

2 years ago
RE: Week 1: Personal Growth and Development

I think there are two major steps to achieve personal growth and development in the workplace: having specific goals and always being willing to learn. In order to achieve personal growth and developm...

In forum Introduction to Medical Device Development

2 years ago
RE: Grades and GPA's in graduate education

The importance of one's GPA soley relies on where you are in your career. At the start of one's career, they are likely going to need a relatively high GPA coupled with some relevant experience. Most ...

In forum Introduction to Medical Device Development

2 years ago
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