@Ahmed-elmonier, good point about claims changing the pathway. It connects to what we talked about with the 510(k) process. To get cleared, a new device has to be shown to be similar to a device alrea...

The 2011 article “Medical Devices and the Public’s Health - The FDA 510(K) Clearance Process at 35 Years” raises two major concerns. First, there is doubt about whether the 510(k) process actually ens...

To show compliance, companies keep a signed consulting agreement, a record of the business need, proof of the work done, and payment records. Fair market value means paying a fair rate for the real se...

M.O.R.E. is a perspective PMI introduced in 2025 as a call to action for project professionals to take accountability beyond meeting success metrics and to deliver value to stakeholders (PMI, 2025). I...

According to the PMBOK Guide, initiation is the process of formally recognizing that a new project exists or that an existing project should continue into its next phase. In practice, it answers the f...

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 ...