In the medical device industry, a primary challenge is to identify, investigate, and resolve deviations in a compliant manner while avoiding significant changes to major design controls. Deviation Management, as defined by the FDA, addresses unexpected or planned events that…   Read more»

Maintaining clear communication among team members in a development project is essential, yet choosing the best communication method can be challenging due to differing personalities and communication styles. Effective communication directly impacts project management success. Several factors can hinder effective…   Read more»

Changes are a normal part of any project, often arising from shifts in the project environment or risks associated with design controls. These modifications to the control process can significantly impact various aspects of project development, and it is essential…   Read more»

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 or evolving the final product. Future project teams should gather insights from past projects…   Read more»

Validation is crucial in assessing test results. In a fast-paced world where immediate answers are required, there is a temptation to prioritize technological innovation to deliver rapid results, often bypassing essential protocols for quality control, verification, and validation. I work…   Read more»

The work breakdown structure (WBS) should be developed alongside scope verification. Together, these two processes enhance the effectiveness of delivering inputs and outputs before moving on to quality assurance. In creating a work breakdown structure, the scope statement serves as…   Read more»

Beforehand, in a project team, there will be interdependence in the different phases of the project, during which, in its development, there will be dynamic circumstances. Hence, one strategy is to establish at the beginning of the project roles and…   Read more»

The project management plan consists of four levels supporting maintaining quality standards. First, Plan cost management lays out the beginning of the production, describing how the project is planned, structured, and controlled in terms of costs, featuring levels of accuracy…   Read more»

The critical path method, a cornerstone of project management, may initially seem daunting due to the extensive processing required to align input and output. However, understanding its importance can help project managers and team members appreciate its value. One way…   Read more»

The work breakdown structure in processes and deliverables occurs after establishing the planning phase by sequence for developing a medical device that can follow design controls. Design controls refer to the systematic process used to manage the design, development, and…   Read more»

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 development. The planning process should be narrowed down into more specific details about each step…   Read more»

Stakeholders’ engagement is needed to contribute to project success and customer satisfaction from the start to the end of the project; it helps to enable success in each phase. The design Development Plan (DDP) lays out the project proposal and…   Read more»

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 compliance with regulatory requirements to support continuous improvement of design controls. At the same time,…   Read more»

Regulatory compliance requires a supportive leadership system that brings along a functional structure in a hierarchical manner to promote quality control in the PDCA cycle as a reassurance of the nature of the project. First, coordination is needed to improve…   Read more»

Since insufficient data can’t provide detailed information and reliability that the treatment for diagnosis of rare diseases is effective, one challenge for patients is insurance coverage. Another pitfall of the Human Device Exemption is bypassing the rigorous regulations established by…   Read more»

One regulatory challenge in developing medical technologies with AI is exploring real-world data in clinical practice. As technology is evolving quickly, regulatory agencies have an urgency to be proactive with guiding principles to promote safety and efficacy in the development…   Read more»