I think the best team outcomes in medical device development come from leadership that prioritizes motivation and culture. Strong management keeps tim...

I agree with your point about a project based organization is the better environment for a project manager because it removes the layered communicatio...

Organizational culture and structure are closely connected because structure sets the framework for how people interact, while culture determines the ...

A strong risk profile captures more than just the hazards associated with a device. It reflects how the device behaves in the real world, how users in...

I agree that eliminating risk entirely is not realistic, especially when dealing with devices that interact directly with the human body. Even when a ...

I agree that several methods can be effective, but I think the task analysis paired with use error analysis offers the clearest picture of how real us...

Some examples of device changes that need to be controlled are updates to the materials used, switching suppliers, or adjusting a device’s size or sha...

I think it really depends on the company and how much they value quality in their process. Some teams tend to see design controls as just another set ...

A contract manufacturer has a lot of responsibility when it comes to process validation. Besides qualifying multiple machines and setting up preventiv...

That’s a really good point about catching design issues early and I actually can relate. From my experience during my internship, I’ve seen how import...

Design control is definitely one of the most important parts of developing a medical device because it helps ensure safety, effectiveness, and regulat...

From my experience as a QC/QA intern at Case Medical, I’ve seen how validation and verification are similar but serve different purposes. Verification...

If I were involved in clinical research, I would want to take on the role of a Clinical Investigator because it connects closely with the kind of work...

That is actually a really good question, and I agree with most of the responses because it seems reasonable to think that only the patient needs to be...

Clinical studies are a vital part of medical progress because they test whether years of lab research can actually improve real lives. For example, th...