While I think transparency is important, one practical reason finances might not necessarily be fully disclosed to a PM is that the budgets are often ...

I believe early stage risk assessments should be prioritized because they help identify major hazards before significant time and resources are invest...

In real world projects, I think these line of phase processes act more as a framework rather than a strict sequence of steps, but alternatively they s...

A lot of great points raised, especially between padding tasks and building structured buffers. Slack management should also be aligned with regulator...

Budget cuts indeed cause an impact on cost estimation, but I would say they also expose weaknesses in the original estimating process. In medical devi...

I agree with the emphasis on the prioritization of safety and regulatory compliance, although I believe there are other important balancing tools for ...

There are a lot of points I agree with, especially those regarding neutrality, early intervention and structured conversations. A good approach would ...

The PM's role does not fully shift from taskmanagement to compliance, but in medical device development, the two could become inseparable. Every task ...

There is an appreciation to what is being said about having an emphasis on humility, documentation and risk management. I agree in regards that emotio...

Understanding hiow the work is divided in a group project is crucial to ensuring both the efficiency and cohesion in the final version of the product....

I agree that in the real world, with a regulated environment in medical device development, there has to be a clear separation between roles while sti...

I personally lean towards the matrix organization, but with an emphasis on a balanced matrix. In biomedical and medical device structures, projects wo...

I think overall in any project or mission, it is important to have a balance of the group size and the AMOUNT of groups as well. With that said, I lik...

I think the most important responsibility of the FDA is risk based protection for public health across the ENTIRE product lifecycle and not just the i...

In addition to verification/validation and post market surveillance, configuration and changes of management could help in the influence of a medical ...