I think another important aspect during design transfer is making sure the manufacturing team really understands the product and how it is supposed to...

If this were to happen in the middle of validation, I think the first step would be to immediately document and record the defects and contact the ven...

A lot of points listed here I agree with, especially with increasing project risk just to shorten the schedule could be a dangerous path, especially i...

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...