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Breaking New Ground: Introducing the Transitional Coverage for Emerging Technologies (TCET) Pathway

July 5, 2023
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Summary of FDA Regulatory Changes for Digital Health Devices in Q3 2022

December 6, 2022
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How to Submit FDA CDRH Submissions Online

July 27, 2022
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A Quantitative Approach to Benefit-Risk Determination

April 21, 2022
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What Are Clinical Benefits and How Do You Evaluate Them in Your CER?

October 27, 2021
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Med Device Monday – Luminopia One, A Digital Therapeutic to Help Treat Amblyopia

October 25, 2021
Blog

How to Prepare a Design History File for FDA Inspection

June 1, 2021
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A Comparison of IVDR to FDA IVD Regulatory Submission Requirements

May 27, 2021
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How to Obtain CE Marking Under the MDR

May 18, 2021
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How to Obtain CE Marking Under the IVDR

April 28, 2021

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