Medical Device made Easy Podcast

Listen Medical Device Regulation and Standards

Last refreshed: June 25th, 2026 at 1:30 AM ⓘ

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Episodes

“We’ve Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices

At first glance, hearing “We’ve never had a complaint” sounds like excellent news. No customer dissatisfaction. No product issues. No safety concerns. But for Quality and Regulatory professionals, this statement should trigger an entirely different question: How do you know? What Is a Complaint? Many organizations believe a complaint only exists when a customer submits an official complaint form or explicitly uses the word “complaint.” Regulators take a much broader view. A complaint may include...

Jun 25, 2026

NC vs CAPA: Are You Opening the Wrong Records?

One of the most common sources of confusion in medical device Quality Management Systems is knowing when to open a Nonconformity (NC) and when to initiate a Corrective and Preventive Action (CAPA). Some organizations turn every issue into a CAPA, while others rarely open one at all. Both extremes can create challenges during audits and may indicate an immature quality system. In this episode of the Medical Device Made Easy Podcast, we explain the fundamental differences between NCs and CAPAs and...

Jun 17, 2026

Best of „AI CE marking“

Artificial intelligence is transforming healthcare, but developing an AI medical device is only part of the challenge. Manufacturers must also navigate certification requirements and maintain safety and performance throughout the entire product lifecycle. In two podcast episodes featuring Sandy Wright and Osman El-Koubani, we explore the journey from certifying LLM-driven medical devices to managing them after CE marking. Certifying LLM-Driven Medical Devices Large Language Models such as ChatGP...

Jun 11, 2026

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