Upper management requires strategic thinking to see the big picture, set long-term goals, and align organizational objectives. It also is important fo...

Organizational structures significantly impact projects and project management by defining authority, communication, and resource allocation. In afunc...

In my time as an intern in the medical device industry, I believe my company worked as a functional organization. The departments mostly worked separa...

It is quite dangerous to mix cost/benefit analysis in with risk analysis and it is not advised to do so. Here's an example of why: Changing the design...

Though risk management is a continuous process and must be done throughout the entirety of a product's lifecycle, I think it is undoubtedly most impor...

I don't think that accepting risk has any effect on the probability of harm. Logically, the only way to affect the probability of harm is to avoid or ...

Design teams prioritize customer feedback by analyzing it against the product’s intended use, market needs, and regulatory requirements. In cases wher...

I agree that it is possible to conduct validation and verification simultaneously in some cases, but that should not be the norm or the goal. It's bes...

To define success criteria, a team should start by thoroughly understanding the device's intended use, regulatory requirements, and user needs. The te...

I think it is very possible for teams to log additional design inputs beyond the basic requirements, especially when trying to anticipate factors impa...

When creating test methods and protocols, key factors include ensuring that the tests accurately simulate the device's real-world use, assessing risk ...

Design controls are critical to mitigating potential risks in product development. They guide the design process to make sure a medical device meets s...

Blinding is a very useful method for researchers to minimize the placebo effect in clinical trials. In single blinding, participants do not know wheth...

I think having a standardized process in place to prepare for unexpected outcomes is always better than not having anything predefined. Without this, ...

If I was involved in a clinical trial, I'd like to work as the clinical research associate. This position speaks to me because it is very hands-on and...