One view is that the best way for organizations to balance innovation with compliance is for Design Controls to be part of the organizations' regular project management processes. The lecture material...

One way to look at this issue is through how the PDCA cycle separates planning from execution. In the accompanying slides it states that the design inputs are the high level customer requirements for ...

The guidance states that the methods used for verification and validation do not need FDA approval before use. However, it says that the methods must be consistent with the FDA's design control system...

In the event of verification failure, the scope of pressurization is often to solve the visible problem, not to see why it did not meet the requirement. In the case of the labels failing under water s...

In medical device development, organizational structure strongly influences how smoothly technical work, testing, and regulatory activities stay aligned. A purely functional organization can build str...

The key differences are whether the device represents such a meaningful change that it raises new questions of safety and effectiveness for patients, and how much new information needs to be obtained ...

Even for someone who does not plan to become a project manager, a working knowledge of project management is still important because most technical roles operate within a structured project environmen...

In group projects, roles should exist, but they should remain flexible rather than fixed. On the other hand, defined roles reduce confusion, missed activities and duplicate work, but on the other, by ...

A useful way to think about project managers, as compared to program managers, is in terms of the level at which they operate. The project manager is responsible for leading the temporary endeavor def...