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 The post Medical Device News June 2026 Regulatory Update appeared first o...
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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 […] The post How can a p...
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Medical Device News May 2026 Regulatory Update
Europe Switzerland UK Events International Podcast Easy Medical Device Social Media to follow The post Medical Device News May 2026 Regulatory Update appeared first on Medical Device made Easy Podcast...
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Can You Certify an LLM-Driven Medical Device?
Large Language Models (LLMs) such as ChatGPT, Gemini, and Claude are rapidly transforming digital healthcare. From clinical decision support to medical documentation and patient interaction, generativ...
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Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand
The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry. Now, Europe is introducing an additional layer: Master UDI-DI — a...
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Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring
Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is not the end of the journey — it […] The post Life A...
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The Fake QMS Problem: Why Your ISO 13485 System Will Fail an Audit
Many medical device companies believe they have a compliant Quality Management System (QMS). On paper, everything looks perfect:• Procedures are written• Forms are available• Risk management is docume...
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