A major stakeholder in medical devices is the healthcare professional who will be using the device. That’s why as part of design controls, a key initi...

Think of it this way - design controls are what you have to do to develop a medical device, project management is how you get it done. Design controls...

The two go hand in hand to form the final business case that allows the project to be chartered. Marketing will do market research to see what the gap...

There are a few communication strategies that can be employed. If sending an email doesn't work, I usually direct message them. If that doesn't work, ...

The previous replies explain the definition of test method validation quite well, but to answer your question simply on the role of TMV in design cont...

Even though the overall structure is similar, in practice, they are executed differently because the actual tests in design verification are completel...

Design reviews are formal, structured meetings that occur at the end of important design controls milestones (at the end of design input, output, veri...

Its true that sometimes it feels like upper management and their timelines are the biggest challenges in a project (and many times that is the actual ...

First, its important to consider the organizational structure when discussing what skills a certain role needs. In regulatory, there will be a departm...