Stakeholder engagement is a critical aspect of clinical trial project management, influencing everything in how a project progresses. However, maintaining effective communication and collaboration amo...

Clinical trials are projects to provide relevant data to show the safety and efficacy of a Class I or Class III device. They're necessary for these devices to be on the market. What are the most preva...

Clinical trials are a decisive method to evaluate the safety and efficacy of a device before they hit the market. "Substantial data" to me is more than just the quantity of tests run, but the quality ...

Human resource management contains strategies to help develop the project team. This includes team building activities, reward systems, trainings, and more. However, all of these things cost money and...

Quality Management is about ensuring that the project meets its goals and meets standards set by regulatory bodies. It includes three main processes: quality planning, quality assurance, and quality c...

Establishing project scope is one of the most vital steps of project initiation. However, it can be incredibly difficult because projects need to have boundaries as to what it encompasses, but it also...

Balancing product innovation and patient safety is only possible with rigorous quality standards and a strict adherence to them. First, performing comprehensive risk assessments on the device during e...

All of the questions above are excellent and I would like to add a few other important ones. "How frequently does the problem occur?" and "Are there any variations between instances?" can help gauge t...

In a medical device project, a robust monitoring and controlling process is crucial in clinical trials. These trials essentially determine the safety and efficacy of your product, so it is critical th...

Once a project closes and it is ready for production, all documents necessary for making the product are handed over to manufacturing and the product goes into production. However, does this mean that...

Schedule Variance (SV) is the quantification of the monetary difference between where the project is (by percent completed and the total budget, not the actual cost) and where the project originally p...

Change control is critical in any medical device company, considering the products that are sold are directly affecting the lives of patients. For this reason, any changes made to these products must ...

Managing internal and external expectations can get really complex. In addition to having clear communication with everyone, critical decisions need to be made with key stakeholders from both the inte...

In this week's mini-sim, the first hurdle to overcome was a management-dictated timeline being ultimately unreasonable without a significant increase in project risk. The preferred outcome to this was...

After this week's lecture, it's not hard to imagine that managing a project can get extremely overwhelming for one person. Especially during the execution of the project, the PM has so many responsibi...