One technique that is truly effective is the work authorization system because it acts as a checkpoint or transition between the planning and action s...

Project management information systems can be argued to be the most essential strategy since they are the central point where aspects such as planning...

Along with avoiding lack of communication and understanding the project requirements from the start, I would like to add that another challenge can oc...

In industry, a PM can rely on types of structured experimental strategies instead of trial and error. The simulation provided the opportunity to set o...

It is also essential to consider a different perspective when it comes to coming back to the previous phase in a project. Overall, it is much less abo...

An interesting perspective that can be overlooked is how individuals who never interact with the project can still be a stakeholder since they are int...

As mentioned, estimation failures can be detrimental in the planning phase of a medical device since they can disrupt budgets and timelines but also t...

A PM has the responsibility to balance FDA expectations, shareholder pressures, and consumer needs. The way they may tackle these objectives is by pri...

An essential difference when it comes to constructing a WBS for medical devices is that it should be built around regulatory readiness as an ongoing p...

I agree, a certification can be complementary to a degree, especially for a PM. However, I would argue that it is also a representation of how much re...

I agree with Krish, a DHF is evidence that the developed device meets regulatory requirements. I would like to add a different perspective as well. It...

As others have mentioned, a methodology for design review can be crucial when assessing changes from a completed project. A perspective that can also ...

Another impact to organizational structure that can be considered, it how accountability and making decisions can speed up a project, especially when ...

A new concept that can be discussed is design controls and regulatory documentation and traceability when animal data affects the product's timeline. ...

In development lifecycle of a medical device, one aspect that hasn't been discussed is how the development life cycle affects verification and validat...