enzo.1216

Forum Replies Created

RE: Why Product Claims Matter in Medical Device Regulation

@31623940 I totally agree. I also wanted to add that I don't necessarily think involving regulatory professionals early in the process would unnecessarily slow down development. There may be situation...

In forum Regulatory Basics for Medical Devices

3 weeks ago
RE: Can Product Claims Make Things More Complicated?

@dcapera I see your point, and after thinking about it more, I agree that starting with fewer claims probably makes more sense. My initial thought was that it might be more efficient to make broader c...

In forum Regulatory Basics for Medical Devices

3 weeks ago
RE: Should AI-Based Medical Devices Require the Same Regulatory Approach as Traditional Medical Devices ?

@ma3295 I agree with your point. I think requiring every AI update to go through the same regulatory process as a completely new medical device could become redundant, especially when the update only ...

In forum Regulatory Basics for Medical Devices

3 weeks ago
RE: Cutting Corners in Research

@dmcclee I totally agree with your point, but unfortunately, as we learned from today’s module, industry does not always set deadlines based on the amount of time the science actually requires. Someti...

In forum Pre-clinical Device Development

1 month ago
RE: Deciding How to Perform Research in Industry

I really enjoyed this topic because I was actually thinking about this question while going through this week’s module. I believe the decision ultimately depends on the resources available and how muc...

In forum Pre-clinical Device Development

1 month ago
RE: Pre-Clinical Research: Academia(Passion) or Industry(Money)?

I also lean toward industry being a stronger contributor to research than academia. I feel like I learned a lot from Dr. Josh Simon’s module this week because it showed me a side of research that I ha...

In forum Pre-clinical Device Development

1 month ago
RE: How Can Project Management Skills Benefit You Without Being a Project Manager?

I totally agree with the perspective that project management skills can benefit people working on a project and are not necessarily only useful for those in leadership positions. I believe having thes...

In forum Intro to Project Management

1 month ago
RE: Pressure vs. Safety: A Project Manager’s Toughest Decision

@ahmed-elmonier I agree with your point that a safety concern does not always mean the entire project needs to stop because a safety concern does not necessarily affect every part of the project. I be...

In forum Intro to Project Management

1 month ago
RE: Teamwork in Projects

@pz98 I totally agree, I believe a person not contributing their share of their work is more problematic than a conflict of ideas. To answer your question of possible ways to get someone to contribute...

In forum Intro to Project Management

1 month ago
RE: Redesigning Medical Devices

if I could redesign one medical device that I have used before it would be the pulse oximeter. Everytime I have used this device at the hospital, it always worked but I remember finding an interesting...

In forum Introduction to Medical Device Development

1 month ago
RE: Thoughts on BME degree, "a little of everything"

@randa I believe it also depends from person to person. I believe that for a major as diverse as Biomedical Engineering, it can sometimes be hard to focus on one particular part and master it when oth...

In forum Introduction to Medical Device Development

1 month ago
RE: Co-Op / Internship Experience

@aq49 I agree, sometimes it is not about the exact experience you acquired but how you word in on your resume that could open doors when applying to jobs. For example an on campus job as simple as eve...

In forum Introduction to Medical Device Development

1 month ago