Hardware Podcasts

215 - Why Aren’t Technical People Leading Drug-Device Audits?

Let's Combinate · 26 Nov 2025 · 13m

What this episode covers

Subhi Saadeh, Founder of Let’s Combinate BioWorks, explains why engineers in pharma and medical devices should become auditors, arguing that technical expertise combined with audit methodology creates the most effective auditors. He details how auditing provides a system-level perspective, revealing how design decisions ripple through Quality Management Systems (QMS) and identifying systemic root causes that isolated engineering work often misses. Saadeh addresses common misconceptions, such as the view that auditing is merely bureaucratic paperwork, and reframes it as a critical tool for building regulatory fluency and career versatility across industries like aerospace and medical devices. He concludes with practical steps for engineers to enter the field, including shadowing internal audits, learning audit frameworks like ISO 13485, and seeking mentorship from experienced professionals.

Most relevant to

early-stage companies

Topics

Mentioned

Also
PDA, ISO 13485, ISO 9001, ISO 15378, ICH Q10, CFRs, ASQ, CQE Academy, Andy Robertson, Rx-360, Combination Products Coalition, ASTM Committee E55, AAMI

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