
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 first on Medical Device made Easy Podcast. hamza benafqir
13 Mar 0s

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 multiple countries. This duplication slows innovation and del...
5 Mar 0s

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-based philosophy introduced in the 3rd edition, the […] The...
26 Feb 0s

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 directly impacts patient safety, regulatory compliance, and produ...
19 Feb 0s

Medical Device News February 2026 Regulatory Update
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 ...
11 Feb 0s

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 podcast episode, Simon Foeger, Founder of SIFO MEDICAL, […] The p...
5 Feb 0s

QMSR Is Coming: Why FDA Inspections Will Change Completely in 2026
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 ...
28 Jan 0s

How to Remediate a Design History File (DHF)
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 fram...
22 Jan 0s



















