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 ...

For most projects, I prefer a smaller sized team (to me that would be around 4 to 6 people). Communication at this size is faster, the roles are clear...

To me, it is crucial understanding ones own role because if a team is to work cohesively, everyone needs to play their part from the top down. It can ...

There a lot of points already mentioned in this thread that I agree with, especially the shift of the project manager role once a device enters that p...

When a conflict between a project manager and a highly skilled member of the team arise, it's important to understand there isn't always a one size fi...

In regards to project management in medical devices, singling out one field as the best fit would be hard. It would be beneficial if some engineer (be...

When it comes to project managers on medical devices, it is important for them to have good analysis on systems coupled with a strong awareness for ri...

When answering this question, I am tempted to say that the risk should strive for a zero-chance, but that is impossible. Devices and products will alw...

There are a few conflicts that could arise when it comes risk management and the project team being involved in the same tasks. One is the distributio...

When discussing mitigation going "too far", I think it is important to analyze whether a control is actually improving the device in an impactful or m...

Whether or not a company utilizes design controls as a tool or a checkbox ultimately comes down to their internal culture and the overall attitude wit...

I think balance really can come down to defining the purpose for each document tier. Perhaps removing informal working logs or notebooks that are not ...

Similarly, as everyone has mentioned, I also believe that this incident (Therac-25) caused a fundamental rethinking and reshaping of how the industry ...