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In Class III manufacturing, time is not just money. It is market share. Use this forensic tool to calculate your daily burn rate.
Calculations based on 2026 FDA/MDR average delay metrics and Class III clinical overhead benchmarks.
Why do we apply a 1.8x risk multiplier to Class III devices? Because the cost of delay is not just operational burn (salaries, rent); it is Market Share Erosion. Industry data confirms that a product launching 6 months late can suffer a 33% reduction in 5-year profitability, compared to just 4% for a 50% budget overrun. In the MedTech "Winner-Takes-All" landscape, second place is often the first loser.
The "Daily Cost" calculation assumes a standard regulatory environment. However, the Feb 2026 QMSR Transition has created a historic backlog. Notified Bodies and FDA reviewers are currently rejecting submissions for minor "Narrative Disconnects" at a record rate. Every "Day of Inaction" currently carries a higher probability of becoming a month of remediation. Speed is your only hedge against this volatility.
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The 10 most common FDA Form 483 findings hitting medical device manufacturers in 2026. Updated for QMSR with actionable fixes from real inspection data.
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