When hiring, whether externally or internally, the PM should consider the project team's size and the need for full-time or part-time availability. Th...

The success of a medical device project depends on stakeholder involvement, among other factors, as their contributions to design, quality, and safety...

Clinical trials, usability testing, and software validation are common methods used in the medical device industry. For example, software validation c...

I have found that the size of the organization or project team has a significant impact on change fatigue. A smaller team struggles to keep up with fr...

Relying too heavily on metrics like EV, PV, and AC can hurt the team when they cannot control the variables that affect them. If the project scope is ...

Incorporating review meetings throughout the project stages is highly recommended for monitoring, and auditors can request a review of the quality of ...

Estimation failures during the planning phase can threaten the project's success, as the project is more likely to have a higher burn rate, increasing...

Performing project quality assurance or monitoring & controlling the project execution are significant for its success. Preventive actions, such a...

Verification includes testing to determine if the inputs match the outputs. Validation, on the other hand, assesses whether the inputs meet the user's...

Someone with a science degree can also become a project manager. If they have additional work experience, they can be attractive to a medical device o...

Testing results should be communicated to stakeholders or senior management, and the project manager will need their approval to proceed with further ...

Early-stage risk assessments are less expensive than addressing the risks as they arise. Taking risks should not come at the expense of safety, and th...

Including costs and resources in the risk management analysis can lower project estimates. Finding alternatives to different resources to mitigate ris...

I had a lab research project that followed a finish-to-start mode, where each task could not begin until the previous task was completed. A finish-to-...

An organization running multiple projects will have many tasks that should ideally be organized, and there are different methods for planning them. De...