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On December 22, 2025, the U.S. FDA updated its list of Recognized Consensus Standards, adding over 100 new and revised entries.

Jan 13

What is the differences and similarities between In-Vitro Diagnostic medical devices (IVD) vs. Laboratory Developed Tests (LDT)?

Jan 6

What is the differences and similarities between In-Vitro Diagnostic medical devices (IVD) vs. Laboratory Developed Tests (LDT)?

What is the differences and similarities between In-Vitro Diagnostic medical devices (IVD) vs. Laboratory Developed Tests (LDT)?

International standard IEC 60812:2018 explains how failure modes and effects analysis (FMEA) is planned, performed, documented and maintained.

Jun 18, 2025

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Couple recent cybersecurity updates

1. CISA (Cybersecurity and Infrastructure Security Agency) with collaborators have issued an updated advisory on Play Ransomware, also...

QV Solutions

Jun 18, 20251 min read

IEC 62304 Revision in Progress: Key Updates

IEC 62304 Revision in Progress: Key Updates

IEC 62304 Revision in Progress: Key Updates

A new revision of IEC 62304, the cornerstone standard for medical device software lifecycle processes, is currently under development....

QV Solutions

Mar 19, 20252 min read

Few Regulatory Updates on AI/ML in Medical Devices:

Few Regulatory Updates on AI/ML in Medical Devices:

Few Regulatory Updates on AI/ML in Medical Devices:

Despite recent FDA-related uncertainty, international regulatory bodies are actively advancing guidance on AI/ML in medical devices. Key...

QV Solutions

Mar 19, 20251 min read

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