Personally, I find that when it comes to making final decisions, differing backgrounds does not have as much impact when there is minimal overlap in r...

While I do think that the PM should be ensuring that the team is keeping regulatory concerns in mind at all stages of the project, I am not sure if de...

While I believe that an online PM is possible, I think that usually an in person PM is generally better though it may depend on the specifics of the p...

I also believe that interpersonal skills are far more important to a PM than technical skills. Like someone else said, the exact technical skills need...

There were a lot of good suggestions in this thread about methods and tools you can implement in a risk management plan. I saw FMEA, and the bowtie me...

I agree that a more dynamic approach to each device would be the best way to handle risk management on any individual project. I do think that you are...

I do not think it is really possible to design a zero-risk device. While certain kinds of risks can be eliminated, some risk will always exist in some...

I think you brought up a great point about validating alternative equipment, in case of equipment failure. I think that in addition to validating alte...

Alot of great points were already brought up in this thread. Trying to keep balance between maintaining up-to-date documentation and balancing ineffic...

While it might be possible that not every real-world failure can be predicted or fixed with design controls, however in this case highlights how desig...

There are many issues and limitations involved with using contract manufacturers. Someone has already brought up ensuring good and consistent QC. Whet...

I generally do agree with the others that one design review is probably not likely to be enough, and while technically following the law is likely not...

Others have already mentioned specifics of using documents like the DID, and DSD to turn broad user needs into specific device specifications. However...

While virtual trials can help with reaching as many patients as possible, this approach has drawbacks to it as well. The main benefit of virtual trial...

GCP is absolutely necessary because innovation is useless, if the methods used to essentially prove the device are not sound. While GCP does involve m...