Medical Device made Easy Podcast

The upcoming EUDAMED deadline on May 28, 2026, marks a major shift in how regulatory data is managed under the EU MDR and IVDR. While many companies believe this transition […] The post EUDAMED Deadli...

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Medboard Europe Team NB UK Solutions RoW Podcast Social Media to follow The post Medical Device News March 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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The global medical device regulatory environment is complex, often requiring manufacturers to repeat similar submissions and audits across multiple countries. This duplication slows innovation and del...

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IEC 60601 has been central to medical electrical equipment safety for decades. From the prescriptive approach of the 2nd edition to the risk-based philosophy introduced in the 3rd edition, the […] The...

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In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that directly impacts patient safety, regulatory compliance, and produ...

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SPONSOR EUROPE  New Harmonization Standards –  Implementing Decision 2026/193:  The conference will feature three breakout sessions focusing on: Switzerland UK Training EasyIFU RoW North America APAC ...

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Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, […] The p...

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For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented.But starting February 2nd, 2026, FDA will implement […] The ...

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