Expert Insights | Regulations

Explore practical guidance to help medical technology teams reduce risk, make informed decisions, and bring life-changing products to patients faster.
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High-Risk IVDs Drive Immediate Transition to IVDR
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Regulations

High-Risk IVDs Drive Immediate Transition to IVDR

March 11, 2025 3 min read
Top 5 Upcoming FDA and EU Regulations – What to Know for 2025
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Regulations

Top 5 Upcoming FDA and EU Regulations – What to Know for 2025

January 13, 2025 4 min read
Is Your Product a Medical Device or a Borderline Product?
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Regulations

Is Your Product a Medical Device or a Borderline Product?

July 25, 2023 2 min read
New Brazil Regulation for Medical Devices Now In Effect – Steps to Take
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Regulations

New Brazil Regulation for Medical Devices Now In Effect – Steps to Take

March 9, 2023 3 min read
Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
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Regulations

Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

January 13, 2023 4 min read
European Union Clinical Trials Regulation: Mandatory Deadline Approaching
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Regulations

European Union Clinical Trials Regulation: Mandatory Deadline Approaching

December 20, 2022 3 min read

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