Medical Device made Easy Podcast Archiv
417 Episoden
1 Minute
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 […]
The post “We’ve Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices appeared first on Medical Device made Easy Podcast. hamza benafqir
The post “We’ve Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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 […]
The post NC vs CAPA: Are You Opening the Wrong Records? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post NC vs CAPA: Are You Opening the Wrong Records? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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 […]
The post Best of „AI CE marking“ appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Best of „AI CE marking“ appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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 on Medical Device made Easy Podcast. hamza benafqir
The post Medical Device News June 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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 […]
The post FEEDBACK AFTER 3 MONTHS OF THE NEW FDA QMSR IS IN PLACE appeared first on Medical Device made Easy Podcast. hamza benafqir
The post FEEDBACK AFTER 3 MONTHS OF THE NEW FDA QMSR IS IN PLACE appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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 proper Intended Use save your device? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post How can a proper Intended Use save your device? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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. hamza benafqir
The post Medical Device News May 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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, generative AI is opening new […]
The post Can You Certify an LLM-Driven Medical Device? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Can You Certify an LLM-Driven Medical Device? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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 — adding both structure […]
The post Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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 After CE Marking: Why AI Medical Devices Need Continuous Monitoring appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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 documented• CAPA systems […]
The post The Fake QMS Problem: Why Your ISO 13485 System Will Fail an Audit appeared first on Medical Device made Easy Podcast. hamza benafqir
The post The Fake QMS Problem: Why Your ISO 13485 System Will Fail an Audit appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
Artificial Intelligence is rapidly transforming the medical device industry, enabling smarter diagnostics, predictive analytics, and personalized healthcare solutions. However, with this innovation comes increased regulatory complexity. In this episode, Camille […]
The post AI Medical Devices: What Notified Bodies Really Look For appeared first on Medical Device made Easy Podcast. hamza benafqir
The post AI Medical Devices: What Notified Bodies Really Look For appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
Medboard EU UK Events RoW Your advertisement must contain: For example, you must not: Podcast Service
The post Medical Device News APRIL 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Medical Device News APRIL 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
The medical device industry is evolving rapidly, driven by stricter regulations, innovation, and global market challenges.To help you stay ahead, we’ve gathered the most valuable insights from three MedTech podcasts […]
The post These 3 podcasts will change how you see MedTech appeared first on Medical Device made Easy Podcast. hamza benafqir
The post These 3 podcasts will change how you see MedTech appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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 Deadline 2026 – 7 Steps Every MedTech Company Must Prepare appeared first on Medical Device made Easy Podcast. hamza benafqir
The post EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare appeared first on Medical Device made Easy Podcast. hamza benafqir
