Medical Device made Easy Podcast

Sponsor Europe UK The line: ‘Alcohol-only pre-injection swabs and wipes are considered to be medical devices as are those containing anti-microbial substances such as chlorhexidine, cetrimide or iodine.’ has been […]The post Medical Device News July 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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

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

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

Sponsor Medboard EUROPE UK Easy Medical Device solutions Rest of the World Podcast Easy Medical Device Social Media to followThe post Medical Device News June 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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

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

Europe Switzerland UK Events International Podcast Easy Medical Device Social Media to followThe post Medical Device News May 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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 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