@dev-doshi, I agree with your point that financial models are important, but they should not be the only factor when deciding whether to invest in medical technology. I believe companies should consid...

I agree that outsourcing can help companies reduce costs and focus on their main areas of expertise. However, I believe that in the medical device industry, cost should not be the only factor when mak...

@aysegultinas, I agree with your point that there should be a balance between protecting innovation and holding medical device companies accountable. I believe leaders in the medical device industry s...

From my experience working in a medical laboratory, I can see why the Cost of Quality is so important. In the lab, we perform quality control, instrument maintenance, calibrations, and specimen checks...

Yes, it can. Too much quality can slow innovation, but in medical devices it is necessary. Quality control is a required part of compliance. A medical device exists to deliver or support patient care....

The QA professional should make the final decision. AI is a useful tool that speeds up analysis, but it is not fully reliable. AI in this scenario can lack data and context needed to reach a conclusio...

@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...