I definitely see medical device project management as being more about the financial and business side rather than just the technical aspects. It’s really about balancing budgets, keeping teams aligne...

I totally agree that project managers (PMs) aren’t traditional leaders but more like advisors or facilitators. They don’t make the actual decisions they just bring together different departments, alig...

I totally agree! Being in the same group, I think our approach worked really well because we took everyone’s ideas into account. Since all of our perspectives were valid, we decided to rank them based...

I totally agree that testing conditions play a huge role in verification failures, and sometimes, the issue isn’t the design itself but how the test is set up. The temperature factor is a big one—37°C...

If we could change the DSD, rather than the verification test. Our strategy would be different. As the DSD specifies product specs, we could tweak bigger aspects of the product. We could change the ad...

The Design Input Document (DID) and Design Specification Document (DSD) are both very important elements of the PDCA (Plan-Do-Check-Act) cycle, but it has an underlying reason for maintaining them sep...