Hardware Podcasts

137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens

Let's Combinate · 22 May 2024 · 18m

What this episode covers

Capt. Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie, and former FDA CDRH official, explains the three levels of reliability in combination products: verification data, component reliability, and system reliability. He details how Fault Tree Analysis (FTA) is used to quantify system reliability, particularly for emergency use injectors and needle safety devices, where the FDA sets specific targets like 95% or 99%. Stevens discusses the regulatory expectations for these high-risk functions and how manufacturers should determine acceptable risk levels when no specific FDA guidance exists, emphasizing the role of risk culture and design assessments.

Most relevant to

large enterprises

Topics

Mentioned

Companies
AbbVie, FDA, CDRH
Tools
FTA, FMEA
Also
QMSR

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