Expert Insights | Medical Devices

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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Laboratory Developed Tests – FDA’s New Proposal
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Medical Devices

Laboratory Developed Tests – FDA’s New Proposal

October 17, 2023 4 min read
FDA’s New Breakpoints in Device Labeling
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Medical Devices

FDA’s New Breakpoints in Device Labeling

October 13, 2023 3 min read
FDA’s NEW Final Guidance on the Breakthrough Devices Program
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Medical Devices

FDA’s NEW Final Guidance on the Breakthrough Devices Program

October 4, 2023 5 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
FDA Updates Their CLIA Waiver Process
Medical Devices

FDA Updates Their CLIA Waiver Process

July 20, 2023 1 min read
Breakthrough Devices Program Updates Device Designations Data and Marketing Authorizations List
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Medical Devices

Breakthrough Devices Program Updates Device Designations Data and Marketing Authorizations List

July 13, 2023 1 min read
Comparing UK MHRA Standalone Software and IMDRF Software as Medical Device Guidance Documents
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Medical Devices

Comparing UK MHRA Standalone Software and IMDRF Software as Medical Device Guidance Documents

June 22, 2023 2 min read
MHRA: Standalone Software and Apps
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Medical Devices

MHRA: Standalone Software and Apps

June 8, 2023 4 min read
Advancing Healthcare Innovation: FDA Explores AI/ML in Drug Development and Devices
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Medical Devices

Advancing Healthcare Innovation: FDA Explores AI/ML in Drug Development and Devices

May 24, 2023 5 min read
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