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 wh...
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Medical Device made Easy Podcast
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Medical Device made Easy Podcast Podcast Guide
Listen to Medical Device made Easy Podcast, a Business podcast by Monir El Azzouzi. Stream 405 episodes in English, follow new audio stories, and play episodes online on Radio and Podcast.
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20 of 405 episodesBest of „AI CE marking“
Artificial intelligence is transforming healthcare, but developing an AI medical device is only part of the challenge. Manufacturers must al...
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 Medic...
FEEDBACK AFTER 3 MONTHS OF THE NEW FDA QMSR IS IN PLACE
The FDA’s new Quality Management System Regulation (QMSR) officially became effective on February 2nd, 2026, replacing the legacy Quality Sy...
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 ep...
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 Regulato...
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...
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,...
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, certific...
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...
AI Medical Devices: What Notified Bodies Really Look For
Artificial Intelligence is rapidly transforming the medical device industry, enabling smarter diagnostics, predictive analytics, and persona...
Medical Device News APRIL 2026 Regulatory Update
Medboard EU UK Events RoW Your advertisement must contain: For example, you must not: Podcast Service The post Medical Device News APRIL 202...
These 3 podcasts will change how you see MedTech
The medical device industry is evolving rapidly, driven by stricter regulations, innovation, and global market challenges.To help you stay a...
EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare
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 c...
Medical Device News March 2026 Regulatory Update
Medboard Europe Team NB UK Solutions RoW Podcast Social Media to follow The post Medical Device News March 2026 Regulatory Update appeared f...
IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals
The global medical device regulatory environment is complex, often requiring manufacturers to repeat similar submissions and audits across m...
IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know
IEC 60601 has been central to medical electrical equipment safety for decades. From the prescriptive approach of the 2nd edition to the risk...
Defect Management in SaMD — From Chaos to Control
In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that direc...
Medical Device News February 2026 Regulatory Update
SPONSOR EUROPE  New Harmonization Standards –  Implementing Decision 2026/193:  The conference will feature three break...
Validation & Supplier Management in MedTech
Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podca...