One major challenge with the Humanitarian Device Exemption (HDE) is the balance between access and safety. Since these devices don’t have to meet the ...

Organizations can make PDCA an ongoing process by making small, frequent improvements instead of treating it as a one-time checklist. One way to do th...

Organizations can balance regulatory compliance and innovation by embedding Design Controls into their everyday workflow rather than treating them as ...

In medical device project management, balancing time, cost, and scope is a constant challenge. While all three are interconnected, I believe time is t...

A good regulatory strategy is important in medical device project management because it helps companies follow the rules, avoid delays, and get their ...

Avoiding PMA in medical device development can slow down innovation. Since PMA takes a long time and costs a lot, many companies choose to improve exi...

I think effective communication within a project team is key to ensuring smooth collaboration and avoiding misunderstandings. While regular meetings a...

A project manager can keep project goals flexible while avoiding scope creep by focusing on prioritization and structured change management. It's impo...

Balancing the needs of stakeholders and customers can be challenging, but project managers need to find a way to meet both sides while keeping the com...

Managing risks from outside factors like supplier delays and supply chain problems is very important. Plans like having backup suppliers, keeping extr...

I believe that technical risks are a major concern in medical device projects because they can lead to serious delays and additional costs if not addr...