Episodes
423
Latest episode
Oct 2026
Language
EN-US
Listen Medical Device Regulation and Standards
Exploring AI-Assisted Clinical Evaluation with Ethan Drower from CiteMed Artificial Intelligence is changing how medical device companies approach documentation, information management, and regulatory activities. One area attracting increasing attention is […] The post Can AI Really Write Your Clinical Evaluation Report? appeared first on Medical Device made Easy Podcast . hamza benafqir
Small Business, Smart Start: AI Without Complex Infrastructure Artificial Intelligence is creating new opportunities for businesses to improve productivity, simplify workflows, and reduce repetitive administrative work. However, for many small […] The post AI Agents for Your Medical Device Business: Where Do You Start? appeared first on Medical Device made Easy Podcast . hamza benafqir
October brings another important round of regulatory developments for the medical device and IVD industry. From updated IVD classification guidance in Europe and potential changes to the UK medical device […] The post Medical Device Regulatory Update – October 2026 appeared first on Medical Device made Easy Podcast . hamza benafqir
Artificial Intelligence may already be part of your Quality Management System, even if your organization has never formally implemented an AI tool. Regulatory Affairs professionals may use ChatGPT to research […] The post AI Is Already Inside Your QMS — But Is It Under Control? appeared first on Medical Device made Easy Podcast . hamza benafqir
Developing complex Software as a Medical Device (SaMD) can quickly become challenging. Requirements, software architecture, dependencies, risk management, verification, regulatory evidence, and cross-functional collaboration all need to work together. But […] The post Vertical Slicing for Complex SaMD Development appeared first on Medical Device made Easy Podcast . hamza benafqir
Quality and Regulatory professionals often find themselves in a frustrating position. They identify a problem, explain the compliance risk and recommend an action. But instead of being seen as protecting […] The post Why Management Doesn’t Listen to Quality—and How to Change That appeared first on Medical Device made Easy Podcast . hamza benafqir
A company says its Medical Device Technical Documentation is 90% or 95% ready. The Risk Management File exists. The Clinical Evaluation is complete. Testing has been performed. The GSPR checklist […] The post Your Technical Documentation Has All the Documents… So Why Isn’t It Ready? appeared first on Medical Device made Easy Podcast . hamza benafqir
Medical device regulation continues to evolve across multiple markets. For manufacturers, the challenge isn’t simply following every new publication—it’s understanding which developments require action, which ones need monitoring, and how […] The post Medical Device Regulatory Update: July & August 2026 appeared first on Medical Device made Easy Podcast . hamza benafqir
Developing a medical device successfully requires several pieces to work together. Manufacturers must demonstrate that the product meets its requirements, maintain reliable design documentation, and understand how regulatory expectations differ—or […] The post From Verification & Validation to Global Market Access | V&V, DHF & IMDRF appeared first on Medical Device made Easy Podcast . hamza benafqir
Bringing a medical device to market requires more than achieving regulatory approval. The decisions made early in product development can influence classification, clinical evidence, risk management, labeling, identification, and ultimately […] The post Regulatory Strategy & Market Access | Intended Use & Master UDI-DI appeared first on Medical Device made Easy Podcast . hamza benafqir
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