I would say the entire cross-functional development team, including engineers. Engineers know how the design should work, manufacturing knows how it actually gets built, service knows how it fails in ...

What could happen if the attachment latch of a powered orthopedic device unlocks during use, how serious could the injury be, and what can engineers do to prevent it?

User training is a type of risk mitigation because it helps reduce mistakes and prevent harm when using medical devices. However, training is considered one of the weakest ways to control risk because...

Engineers should start making the device when they have checked all the possible dangers, fixed or planned for each one, and tested the final version to show it works safely and lasts. They should als...

The regulation defines verification as confirming that 'specified requirements' are fulfilled, and design validation as confirming that device specifications conform with 'user needs and intended use'...

Subjective user needs are transformed into measurable requirements during the design input process, where qualitative expectations are translated into specific, testable criteria. These requirements a...

I agree with your point @ha572 that preclinical results, especially from animal testing, can’t fully predict how a device will perform in people. That’s exactly why clinical trials are necessary, and ...

@jacobthomas64 Nice summary! I agree that clinical research needs many groups working together, and that GCP and ethics boards are key to protecting patients. On your questions, I think money and eth...

I agree that virtual clinical trials may substitute for some human studies, particularly in early dose-finding, trial design, and the use of synthetic control arms, but I do not believe they can fully...

@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...