Hardware Podcasts

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

Let's Combinate · 15 Jul 2026 · 8m

What this episode covers

Subhi Saadeh, a quality consultant specializing in drug-device combination products, explains the three primary structures for Quality Management Systems: centralized, decentralized, and federated. He details how document hierarchies differ across these models, noting that centralized systems rely on global SOPs while decentralized ones allow local autonomy. Saadeh argues that governance and clear decision rights are more critical to success than the specific operating model chosen, as this is where systems often fail.

Most relevant to

large enterprises

Topics

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