Hardware Podcasts

256 - The New FDA Inspection Playbook: Where to Start with QMSR

Let's Combinate · 28 Sept 2026 · 9m

What this episode covers

Subhi Saadeh, founder of Let’s Combinate, introduces a four-part series on FDA inspection readiness under the new Quality Management System Regulation (QMSR), explaining how the retired QSIT framework has been replaced by Compliance Program 7382.850. He highlights advice from former FDA investigator Eric Pittman, who advises industry to focus exclusively on Section III of compliance programs as the primary roadmap for inspections. The episode details the shift from QSIT’s four major subsystems to six QMS areas, emphasizing a risk-based approach where investigators evaluate product risks and control effectiveness.

Most relevant to

large enterprises

Topics

Mentioned

Companies
FDA, Let’s Combinate
Also
QMSR, QSIT, ISO 13485, Compliance Program 7382.850

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