One consideration when it comes to the length of times associated with change orders is the regulatory body a project manager is dealing with. The FDA and the EUMDR have different processes when it co...

Curing patients could be a sustainable business practice, however it does not seem reasonable. With a business model that prioritizes curing patients, a plethora of ethical dilemmas could come into pl...

One important aspect of task scheduling that hasn't been mentioned is the important of incorporating slack when scheduling tasks. Slack is important to a project as it allows for a project manager and...

Scope management directly influences the cost and time management of a project. As the scope increases, it comes with the expense of a higher cost (usually). Increasing scope can also alter the timeli...

A project can be well-coordinated while taking account into the 10 knowledge areas is the implementation of a change control process. Managing the 10 knowledge areas and coordinating all elements with...

In regards to the initiation process in medical device projects, one key input is risk management and planning to mitigate risk. This input is often overlooked by many as risk management may not be ta...

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...