This is a really great topic, and I do think that the answer to which types of risks are more predominant and the most impactful depend on the industr...

Another very useful tool is the Work Breakdown Structure. It essentially helps define the project scope better and breaks it down into the larger func...

I agree with the posts above. Indentifying the critical path will aid in a seamless execution of the project. Another tool I find to be helpful is a p...

Gantt charts are a great tool especially for sticking to the project timeline in a visual manner. However, sometimes these charts do not offer flexibi...

Some other things to keep in mind are ensuring that you are up-to-date with all the regulations and standards/qualifications that must be met. The FDA...

Hi everyone! My name is Priyanshi Luhar and I'm a student at NJIT in the BS/MS program studying biomedical engineering. I'm also currently doing a co-...

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...