Hardware Podcasts

188 – Certified Quality Auditor(CQA) and Audits in the Future

Let's Combinate · 14 May 2025 · 15m

What this episode covers

Subhi Saadeh, an ISO 13485 certified lead auditor and host of Let's Combinate, discusses the evolving role of auditing in the medical device and pharmaceutical industries. He reflects on his recent acquisition of the Certified Quality Auditor (CQA) credential and outlines the key qualities that distinguish great auditors, such as risk-based decision-making and the ability to trace issues across systems. Saadeh argues that while AI can streamline tasks like trend analysis and traceability, it cannot replace the human judgment, cultural assessment, and adaptability required for effective audits.

Most relevant to

established companies

Topics

Mentioned

Tools
Spotfire
Also
Let's Combinate, ISO 13485, CQA, ICHQ10, CFR 820.50, ASTM Committee E55, AAMI, Combination Products Coalition

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