Recent Posts
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The Audit Readiness Myth: Why Most Startups Aren’t As Prepared As They Think
Many medical device startups assume they’re audit ready because they have documented procedures, completed templates, and a Quality Management System in place. However, successful audits require much more than organized […]
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The FDA Clearance Journey: What Nobody Tells Medical Device Startups
For many medical device startups, obtaining FDA clearance seems like a clear, linear process. Identify a predicate device. Prepare your documentation. Submit your application. Wait for clearance. In reality, the […]
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The Audit Went Perfectly… So Why Are We Still in Trouble?
For many medical device companies, a successful audit is seen as the ultimate proof that their Quality Management System is performing well. Few or no findings. Positive feedback from auditors. […]
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Medical Device News July 2026 Regulatory Update
Stay up to date with the latest EU MDR, IVDR, UK MDR and Swiss Medical Device regulations. In this episode we cover: 🤝 Episode Sponsor Medboard 👉 MedBoard – The […]
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“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 […]
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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 […]
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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 […]
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Medical Device News June 2026 Regulatory Update
Sponsor Medboard EUROPE UK Easy Medical Device solutions Rest of the World Podcast Easy Medical Device Social Media to follow
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FEEDBACK AFTER 3 MONTHS OF THE NEW FDA QMSR IS IN PLACEÂ
The FDA’s new Quality Management System Regulation (QMSR) officially became effective on February 2nd, 2026, replacing the legacy Quality System Regulation (QSR) framework that had been in place for nearly […]
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How can a proper Intended Use save your device?
A medical device’s intended use is not just a regulatory formality — it is the foundation of the entire product strategy. In this podcast episode, Monir El Azzouzi speaks with […]
