Hardware Podcasts

244 - 5 Critical Quality Differences Between Drugs and Devices

Let's Combinate · 1 Jul 2026 · 8m

What this episode covers

Subhi Saadeh, a consultant specializing in drug-device combination products, explains five critical quality differences between pharmaceuticals and medical devices. He contrasts the drug industry's focus on consistent manufacturing of clinically proven products (ICH Q8/Q9) with the device industry's emphasis on design robustness and user needs (ISO 13485/14971). The discussion covers divergent approaches to risk management, regulatory submission evidence, and lifecycle change control, urging teams to intentionally integrate these systems rather than forcing one onto the other.

Most relevant to

established companies

Topics

Mentioned

Also
ICH Q8, ISO 13485, ICH Q9, ISO 14971, ICH Q12

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