I agree with the points above. Changing the DSD is a more difficult process compared to the test veriffication plan. However, my decision on whether o...

My group performed similarly. We took a more collaborative approach. We first did a root cause analysis and identified the areas of error that could h...

You bring up a really good point that I think is highly debated in this high stakes industry. Medical device developers will try to increase the scope...

From my experience in the med tech field, I've learned that companies take measures so that devices don't have to be redesigned. The device is made ta...

Design changes can occur due to wanteding to improve the medical device or wanting to fix any issues it may have. In wach case, it is good to have a l...

Having design reviews regularly shows the progression of the project and ensures that it is on the right track. Something that I think would be benefi...

While the long and challenging process for a PMA make it so that companies are discouraged at innovating new medical devices, it is necessary for a PM...

I agree that sometimes it is difficult to classify a medical device, especially if it is a combination product. Having a combination product brings in...

A project's scope is based on customer needs and stakeholder values. Stakeholders are most invested in the financial situation with the project, while...

Something that is told very frequently at medical device (or anything healthcare or biotech related) companies is to focus on the "why". Before jumpin...

I think the previous posts bring up great points in having transparency to maintain a clear line of communication. I agree that messages may become un...