Hardware Podcasts

204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle

Let's Combinate · 3 Sept 2025 · 32m

What this episode covers

Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and author of The Combination Products Handbook, explains the persistent regulatory confusion surrounding terminology in drug-device combination products. She details how terms like 'platform,' 'component,' and 'CAPA' are interpreted differently between pharmaceutical and medical device frameworks, creating significant compliance risks. The discussion highlights the failure of ASTM standards to align global definitions and emphasizes the need for a science- and risk-based approach to navigate these discrepancies.

Most relevant to

established companies

Topics

Mentioned

Products
The Combination Products Handbook
Also
ASTM International, FDA, ISO 13485, ICH Q8, ICH Q9, ICH Q10, 21 CFR 211, 21 CFR 820, EU MDR, QMSR

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