A well-structured Design and Development Plan (DDP) is essential for medical device projects, ensuring that design activities align with regulatory re...

A well-maintained Design History File (DHF) is essential for both regulatory compliance and efficient project management. Beyond just documentation, t...

The PDCA cycle is indeed crucial for ensuring continuous improvement and regulatory compliance in medical device projects. However, to fully integrate...

The FDA’s approval of Abilify MyCite in 2017 marked a significant step in digital pill technology, combining a traditional antipsychotic medication wi...

During the lecture, my question was raised regarding the FDA’s role in evaluating medical devices. My understanding is that the FDA prioritizes safety...

This topic raises an important question about the flexibility of medical device classification, particularly in ambiguous cases. In reality, the class...

It is highly beneficial for both the project team as a whole and individuals in non-PM roles, such as engineers or scientists, to have a solid underst...

The decision to adapt a new technology in an ongoing project requires careful consideration from the project manager. Before implementing any new appr...

The responses above effectively highlight the fundamental differences between drugs and medical devices, particularly emphasizing that drugs typically...