Keeping all these details in mind, I think a balance of both perspectives can be valid depending on the product and the function of that product. Mimi...

Design change requests in medical device development are definitely a challenge I agree. An idea on how a company can handle these change requests is ...

I think the previous post has made some excellent posts and definitely highlights the potential problems with this exemption program from the FDA. How...

I agree that companies can utilize techniques to create a DDP that is both structured but flexible such as a Gantt chart. Gantt charts are great at ke...

@bryan-xavier Your information about the Breakthrough Devices Program definitely changed my own view about this topic I created. When I found out abou...

I agree with the previous claims of underestimating regulatory requirements from the start. To add to that, picking the wrong classification of your m...

I agree for the most part that regulatory process may be a big risk in the medical device project management. However my opinion is more that the tech...

I think the biggest challenge in managing medical device projects is regulatory hurdles. Regulatory hurdles can put a heavy impact on your medical dev...

I think the biggest challenge out of the triple constraint is scope. Scope has to be almost perfectly planned out before the medical device developmen...