Hardware Podcasts

093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle

Let's Combinate · 12 Jul 2023 · 25m

What this episode covers

Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and author of 'The Combination Products Handbook', discusses advanced topics in combination product development with host Subi Saadeh. They cover supplier management nuances, specifically the risks of relying on 'medical grade' claims and the critical need for prior approval of supplier changes. The conversation also addresses analytical testing for biologics, highlighting compatibility issues between drug formulations and device constituents, and the evolving regulatory landscape for digital health and global combination products.

Most relevant to

established companies

Topics

Mentioned

Companies
Combination Products Consulting Services LLC, Taylor & Francis Group, Johnson & Johnson, ISPE, ASTM International, AAMI, UMBC, DIA, RAPS, FDA
Also
The Combination Products Handbook: A Practical Guide, 21 CFR 820, ISO 10993, Fran de Grazio, Mira R., Daniel Bance, Jennifer Ryder, Manfred Mater, Stephanie Google, Vicki Vernon, Sherry Marty, Raj Bell

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