I agree that real-time monitoring is the best way an organization can create a culture that embraces the PDCA cycle. As mentioned, regularly scheduled...

I agree that it is unwise to jump to design modifications without performing additional tests. It is necessary to pin point where the problem is befor...

I think it could be necessary to vary testing parameters within regulatory guidelines to come to a favorable outcome after failure. Though it may be d...

I agree with the above, well-defined roles are crucial to the long-term success of a project team. It is best to allow group members to define their r...

I agree with what has been said above, that determining specs is an extremely important and delicate part of the design process. The specs must be tig...

I agree that the largest challenge that would come with misclassifying a device is stunting your timeline. Additionally, more resources and a deeper b...

I agree that AI-driven medical devices should be even more highly regulated than other devices because of their potential to evolve over time. I think...

Drugs and medical devices are quite different and their general regulatory pathways reflect those differences. A medical device is some sort of mechan...

I'd also agree that inadequate risk management is the most common regulatory pitfall in medical device development. Classification of the device can b...

I'm quite surprised by all the previous responses choosing the hands-off approach to project managing, because I think there are a lot of benefits to ...

Generally, the most effective communication is early and often. This applies to all walks of life, not just project management. Specifically on a proj...

I anticipate the biggest risks in medical device project management in the regulatory process. The road to regulatory approval for medical devices in ...

An unreasonable location for a sponsored event could be an exotic destination far from the offices of the employees traveling there. Even so, employee...

What I think is a major requirement that could be made into a hypothetical international contract law is a mandatory ethical compliance clause. This w...

To maintain a balance between abiding by an NDA and ensuring transparency, companies should draft NDAs that are very specific, clearly outlining what ...