In the medical device industry, a primary challenge is to identify, investigate, and resolve deviations in a compliant manner while avoiding significa...

Maintaining clear communication among team members in a development project is essential, yet choosing the best communication method can be challengin...

Changes are a normal part of any project, often arising from shifts in the project environment or risks associated with design controls. These modific...

The success of a project largely depends on the closing phase. This phase is critical for generating insights that can lead to new ideas for improving...

Validation is crucial in assessing test results. In a fast-paced world where immediate answers are required, there is a temptation to prioritize techn...

The work breakdown structure (WBS) should be developed alongside scope verification. Together, these two processes enhance the effectiveness of delive...

Beforehand, in a project team, there will be interdependence in the different phases of the project, during which, in its development, there will be d...

The project management plan consists of four levels supporting maintaining quality standards. First, Plan cost management lays out the beginning of th...

The critical path method, a cornerstone of project management, may initially seem daunting due to the extensive processing required to align input and...

The work breakdown structure in processes and deliverables occurs after establishing the planning phase by sequence for developing a medical device th...

Generally, when planning, project teams have a broad picture of the goal or process in aim but typically forget the sudden risks found during the deve...

Stakeholders’ engagement is needed to contribute to project success and customer satisfaction from the start to the end of the project; it helps to en...

The DHF should be treated as an essential asset for quality control of the design controls process since it is the set of documents ensuring complianc...