A structured, continuous approach to risk assessment, as outlined in ISO 14971, is key to preventing overlooked hazards. Narrowing the planning proces...

Project managers often factor in potential delays, and missing a milestone sometimes yields benefits—like uncovering technical flaws that improve the ...

Balancing rigorous design controls with innovation is a crucial element in medical device development, ensuring compliance and the continuous evolutio...

I think having a basic understanding of project management is valuable, even if someone isn’t planning to pursue it as a career. In industries like me...

When dealing with verification failures in a project, I always find that a structured problem-solving approach is the best way forward. In the case of...

f we’re running verification tests to check the specs, inputs, and outputs from the DSD, the probability of needing a budget change depends largely on...

Companies should embed regulatory planning into every stage of product development rather than waiting until the latter phases. Involving regulatory s...

Sizes of project teams must directly reflect the amount of responsibility that is needed in the completion of it. I do prefer smaller teams since I fe...

When transitioning to new technologies during an ongoing project, one thing to ensure is to stay compliant with regulations. Sometimes just merely cha...