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...

I can understand where you're coming from when you mention that the merging of companies can create fragmented quality systems, which in turn slows co...

As is the case for any team, communication between members is key to success. When scaled to a larger size, communication between departments is how a...

I don’t have any experience with audits, but I like the idea of viewing audits as learning tools rather than check-ins that create more work. However,...

From what I gathered from our week 4 lecture video, it appears that a lot of people in regulatory affairs actually come from a research or lab backgro...

One example that comes to mind is not exactly a natural outbreak, but the Tuskegee Syphilis Study in the United States. This was a 40 year long study,...

Compared to pharmaceuticals, where refinement of a drug is through a fixed and repetitive pipeline, clinical trials for medical devices serve two majo...