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Introduction to Design Controls
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The Therac-25 radiation therapy machine (1985–1987) caused multiple fatal overdoses due to software design flaws and inadequate verification. Engineers reused old code and skipped redundancy testing — clear failures of design controls we take for granted today. This case shaped modern standards like IEC 62304 and ISO 13485.
Do you think our current design control systems are strong enough to prevent a modern “Therac moment” especially with AI and complex algorithms entering the medical device space?
Reference: https://en.wikipedia.org/wiki/Therac-25
Posted : 05/11/2025 9:49 pm
