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Bracing for Impact on Trump's Tariffs Towards MedTech
Alex Chang 4/8/25 Alex Chang 4/8/25

Bracing for Impact on Trump's Tariffs Towards MedTech

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FDA's Stalled Journey to Regulate LDTs and the Final Nail in the Coffin
Alex Chang 4/5/25 Alex Chang 4/5/25

FDA's Stalled Journey to Regulate LDTs and the Final Nail in the Coffin

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Massive FDA Layoffs Spark Outrage and Uncertainty
Alex Chang 4/3/25 Alex Chang 4/3/25

Massive FDA Layoffs Spark Outrage and Uncertainty

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Things to consider in 2025 - Europe's Health Data Space Act
Alex Chang 2/2/25 Alex Chang 2/2/25

Things to consider in 2025 - Europe's Health Data Space Act

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Social Media and DTC advertising for Medical Device Companies in the USA
Alex Chang 12/1/24 Alex Chang 12/1/24

Social Media and DTC advertising for Medical Device Companies in the USA

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Updates on the Gradual Rollout of EUDAMED - 2025 and Beyond
Alex Chang 10/14/24 Alex Chang 10/14/24

Updates on the Gradual Rollout of EUDAMED - 2025 and Beyond

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Cybersecurity Considerations for FDA Medical Device Submissions
Alex Chang 8/11/24 Alex Chang 8/11/24

Cybersecurity Considerations for FDA Medical Device Submissions

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The EU Artificial Intelligence Act: Enforcement Rules, Timeline and Penalties for Medical Device Manufacturers
Alex Chang 7/8/24 Alex Chang 7/8/24

The EU Artificial Intelligence Act: Enforcement Rules, Timeline and Penalties for Medical Device Manufacturers

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Japan's Regulation on SaMD
Alex Chang 6/24/24 Alex Chang 6/24/24

Japan's Regulation on SaMD

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FDA's Final Rule Incorporating ISO 13485 into their new QMSR
Alex Chang 6/9/24 Alex Chang 6/9/24

FDA's Final Rule Incorporating ISO 13485 into their new QMSR

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