Medical Device made Easy Podcast

Medical Device made Easy Podcast

Listen Medical Device Regulation and Standards

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Avsnitt(403)

Medical Device News March 2026 Regulatory Update

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 Mars 0s

IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals

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 Mars 0s

IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know

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

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

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 & 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

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)

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

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