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 aligned, and making sure deadlines are met, all while ensuring the…   Read more»

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, align goals with the company’s interests, and make sure everything runs smoothly….   Read more»

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 on feasibility and potential impact….   Read more»

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 is definitely going to affect…   Read more»

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 adhesive formula, the surface treatment, and…   Read more»

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 separately. The DID records the general requirements and expectations of the…   Read more»