I agree that a more dynamic approach to each device would be the best way to handle risk management on any individual project. I do think that you are correct, that maybe there may not be enough empha...

FMEA is a recommended tool for identifying potential failures early in the development phase, as well as their effects and the recommended actions to be taken. Global organizations such as the Six Sig...

While modern design control systems like ISO 13485, IEC 62304, and FDA 21 CFR 820 are far stronger than those in the Therac-25 era—mandating rigorous verification, risk management, and traceability—th...

AI driven and adaptive algorithms in medical devices introduce a new layer of uncertainty. Unlike deterministic systems, machine learning models can behave unpredictably outside trained data sets. Ver...

What contributed to the Therac-25 incidents was a reliance on old code as mentioned in previous posts. Engineers possibly assumed their code from previous projects was fine as is. With AI entering med...

While many have raised valid points about adaptive algorithms and overconfidence in structured systems, I think a modern “Therac moment” could result less from technical gaps and more from ethical and...

I think our current design control systems have definitely come a long way since the Therac-25 incident, but I’m not sure they’re strong enough to completely prevent a modern “Therac moment,” especial...

Similarly, as everyone has mentioned, I also believe that this incident (Therac-25) caused a fundamental rethinking and reshaping of how the industry approaches both software safety and design. With t...

I think our current design control systems are much stronger, but not entirely error-proof. The Therac-25 tragedy definitely pushed the industry toward stricter verification, documentation, and risk m...

I agree that the Therac-25 incident changed how we think about design controls; however, I think that the next "Therac moment” might come from overconfidence in verification rather than poor verificat...

The Therac-25 disaster serves as a poignant reminder of the vital importance of design controls and verifications in medical device development. I realize that modern frameworks (e.g., IEC 62304 and I...

I think many companies initially treat design controls as a regulatory checkbox, especially smaller startups rushing toward 510(k) or PMA submission. However, the organizations that truly excel in pro...

Following design controls intentionally is important for efficiency, even if it feels like it's there just for compliance. A lot of it feels like regulatory checkboxes, but it can benefit a project te...

Whether or not a company utilizes design controls as a tool or a checkbox ultimately comes down to their internal culture and the overall attitude within. Companies, whether big or small, that value a...

I believe that many businesses, particularly smaller ones that are under pressure to launch a product quickly, first view design controls as merely another regulatory box to check. It's simple to thin...