A well-structured Design and Development Plan (DDP) is essential for medical device projects, ensuring that design activities align with regulatory requirements and user needs. Beyond just documentation, a dynamic DDP allows for traceability and adaptability throughout the development lifecycle. Take…   Read more»

A well-maintained Design History File (DHF) is essential for both regulatory compliance and efficient project management. Beyond just documentation, the DHF should serve as a real-time tool for design control and traceability. Companies can ensure an audit-ready DHF without slowing…   Read more»

The PDCA cycle is indeed crucial for ensuring continuous improvement and regulatory compliance in medical device projects. However, to fully integrate PDCA as an ongoing process rather than a one-time compliance exercise, organizations need to focus on both cultural and…   Read more»

The FDA’s approval of Abilify MyCite in 2017 marked a significant step in digital pill technology, combining a traditional antipsychotic medication with an ingestible sensor to track adherence. While this innovation introduced a new approach to monitoring medication intake, its…   Read more»

During the lecture, my question was raised regarding the FDA’s role in evaluating medical devices. My understanding is that the FDA prioritizes safety over effectiveness—they do not conduct independent tests to verify a product’s efficacy as described in regulatory filings….   Read more»

This topic raises an important question about the flexibility of medical device classification, particularly in ambiguous cases. In reality, the classification process inherently involves many grey areas, and real-world cases tend to be even more complex. Since regulatory decisions involve…   Read more»

The responses above effectively highlight the fundamental differences between drugs and medical devices, particularly emphasizing that drugs typically involve a chemical reaction. However, I would like to raise an additional question—or perhaps explore what might be considered a vague definition—regarding…   Read more»

The decision to adapt a new technology in an ongoing project requires careful consideration from the project manager. Before implementing any new approach or model, priority should be given to quality control and risk management to ensure the new technology…   Read more»

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 understanding of project management principles. For the team, this shared knowledge fosters a smoother…   Read more»