I think it's important first to define what quality assurance and quality control's main roles are within the field of medical device development. Quality assurance (QA) is a proactive, process-focuse...

One critical stage in the medical device concept-to-market process that is often overlooked and treated as an afterthought is proper documentation of the design control process. The Design History Fil...

AI has been evolving in healthcare since the 1970s, beginning with expert systems such as MYCIN, which helped diagnose bacterial infections using “if-then” rules. By the 1990s, neural networks were be...

My professional and academic journey has taken several unexpected turns, but each experience has helped me better understand my interests and goals. I initially studied Bilingual Education, however, I...

* The ultimate question is are the devices that are being approved are they safe and have all the steps been taken to assure this? Six years have passed since the outbreak of the COVID-19 pandemic, an...

* Would some of you perhaps prefer a combination of industry/academia? Or maybe foresee a transition to one or the other later in your career? From my professional experience, I believe that combining...

Human Resources Management primarily focuses on creating and maintaining a positive environment within the organization to drive its goals and align with its objectives. The PMBOK guide presents vario...

Uncertainty is an inherent part of many projects, which can lead to discouragement among team members. It is important to address this uncertainty within the project's performance domain. There are se...

In BoneFix's scenario, uncertainty arises in the performance domain, leading to a lack of understanding and awareness of issues, events, paths to follow, and solutions to pursue. This unpredictability...

I have observed a lack of communication at different stages of projects, with this issue being most prevalent during the execution phase. In the planning phase, team members are usually excited about ...

Monitoring and controlling are important aspects from both project management (PM) and clinical research perspectives. In project management, the goal is to ensure that the project stays on schedule, ...

Understanding the clinical trials process involves delivering results through a service that fosters progressive collaboration, relying on clear communication. Underperformance becomes evident when it...

Human Resource Management involves the art and science of directing and coordinating human resources throughout a project’s lifecycle. Organizational planning is the process of selecting development a...

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 Man...

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...