Medical Device made Easy Podcast

IEC 60601 has been central to medical electrical equipment safety for decades. From the prescriptive approach of the 2nd edition to the risk-based philosophy introduced in the 3rd edition, the […]The post IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know appeared first on Medical Device made Easy Podcast. hamza benafqir

In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that directly impacts patient safety, regulatory compliance, and product […]The post Defect Management in SaMD — From Chaos to Control appeared first on Medical Device made Easy Podcast. hamza benafqir

SPONSOR EUROPE New Harmonization Standards – Implementing Decision 2026/193: The conference will feature three breakout sessions focusing on: Switzerland UK Training EasyIFU RoW North America APAC Africa: https://eservicesdata.edaegypt.gov.eg/MedicalDevices Middle East […]The post Medical Device News February 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, […]The post Validation & Supplier Management in MedTech appeared first on Medical Device made Easy Podcast. hamza benafqir

For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented.But starting February 2nd, 2026, FDA will implement […]The post QMSR Is Coming: Why FDA Inspections Will Change Completely in 2026 appeared first on Medical Device made Easy Podcast. hamza benafqir

Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during audits, inspections, acquisitions, or regulatory framework changes. In […]The post How to Remediate a Design History File (DHF) appeared first on Medical Device made Easy Podcast. hamza benafqir

Social Media to followThe post Medical Device News January 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it remains one of the most challenging phases for many […]The post Verification & Validation Explained — A Practical Conversation with Aaron Joseph appeared first on Medical Device made Easy Podcast. hamza benafqir

As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key priorities shaping 2026. The episode reflects […]The post Last Podcast of the Year – Easy Medical Device | Year in Review & What’s Next appeared first on Medical Device made Easy Podcast. hamza benafqir

The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR […]The post Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal appeared first on Medical Device made Easy Podcast. hamza benafqir