While in some industries verbal agreements can work for small, low risk situations, when it comes to the medical device industry I really don’t think ...

I think an agreement starts to become suspicious long before anything blatantly illegal happens. There can sometimes be early warning signs: 1. When...

I think clearer numerical standards could help, but they might not fully solve the overlapping problem. Even if the industry set strict limits, for ex...

I agree that the structure itself isn’t necessarily the issue it’s how communication and expectations are managed within it. One of the biggest “secre...

You both make great points about the importance of clearly defining roles and responsibilities to prevent overlap. I would add that another effective ...

In my experience, the most effective usability risk strategy is the one that ties real user behavior directly to risk controls. For example, during my...

I think this is a great question because it is definitely something that isn't talked about often. When working on my capstone project, my team and I ...

First and foremost, it is important to understand that the critical characteristics of the risk profile for a medical device include the key attribute...

As the use of AI becomes more prominent in our society, I think you’re right to frame AI as both an opportunity and a challenge in medical device mark...

This is a great question to ask, especially in today's technologically advanced society where physicians are now able to provide telehealth services. ...

I can definitely understand why an LLC would be an appealing choice when considering how to start a business, however, I lean more towards the sole pr...

When it comes to experiencing leadership styles in both a corporate and academic setting, I can say that I have been very fortunate to have mentors an...