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 like working in smaller groups due to the communicati...

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 initial approval. While the safety and efficacy rev...

In addition to verification/validation and post market surveillance, configuration and changes of management could help in the influence of a medical device's product life cycle. As time goes on and t...

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 and concise, and it is an easier task keeping eve...

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 be frustrating having to pick up the slack for som...

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 post market phase. I think an aspect that has not y...

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 fits all. In one aspect, it depends on the competenc...

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 it biomedical or other) would be a good fit, but ...

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 risks in the field. Biomedical projects and devices ...

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 always carry some risk, although they will be put to ...

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 distribution workload for the project. Having the same group ...

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 meaningful way, rather than just being work to plac...

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 within. Companies, whether big or small, that value a...

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 officially updated changes in the DDP (such as des...

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