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Category: Insight
November 19th 2025

Beyond the Valley of Death: What MedTech Innovators Must Get Right
November 18th 2025

FDA 510(k) Pathway and Opportunities Introduction
November 13th 2025

ISO 42001 for MedTech: Managing Risk and Building AI Trust
November 11th 2025

Compliance as a Growth Enabler: Commercial Lessons from the MDR/FDA Front Lines
November 10th 2025

Reimagining Organ Preservation: How Machine Perfusion is Redefining Viability of Donor Organs
November 7th 2025

The Double-Edged Role of Plastics in Global Healthcare
November 6th 2025

The Urgent Case for Radical Collaboration in MedTech
November 4th 2025

IEC 62304 in Medical Technology: Safe and Regulatory-Compliant Medical Software
October 29th 2025

As MedDev’s Data Footprint Grows, ISO/IEC 27701 Sets the Standard for Privacy and Trust
October 29th 2025

Bridging Innovation and Compliance: Why Early Regulatory Integration Saves Startups