The FDA should have some indirect impact on verification and validation tests. Ideally, these would be guidelines for companies should follow, but should not be strict standards. Regulatory requiremen...

EEFS should be considered multiple times during the project management lifecycle. As with risk management, holding regular meetings to assess EEFS is critical for the success of a project. Communicati...

One main factor that can contribute to how a project management could set up a project organization can be based off of the overall status of the team communication and collaboration. Project-based or...

Traceability and adaptability requires a systemic change control process in order to maintain efficiency. One example of this would be features embedded within digital project management tools. A trac...

One product that comes to mind when discussing product life cycles is the stethoscope. The acoustic stethoscope has been used since at least the 1850s and has stayed as a reliable tool for clinicians....

Intended use and the technological features of a device is usually the focus when determining which regulations apply to a product. Small distinctions in the function of a medical device can solidify ...

Hurdles may not be the right term to use when accidently classifying a device as a Class III instead of a Class II. From a project management prospective, misclassifying a medical device within the wr...

Regulatory agencies should feel the need to adapt faster to keep up with the innovation happening in the medical device field. As it was mentioned, AI may become much more prominent in modern medical ...

@ms3548 Underestimating regulatory requirements is indeed a common pitfall that does not get enough attention in my view. Implementing steps for early and continuous regulatory engagement can ensure a...

An essential strategy for avoiding scope creep and delivering a successful project is developing a dynamic risk management strategy. Dynamic risk management is based upon the idea that it can catch sc...