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MDCG 2023-4: Medical Device Software (MDSW) – Hardware Combinations

Posted 1 year and 2 months ago

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FDA Releases “Predetermined Change Control Plans for Machine Learning – Enabled Medical Devices: Guiding Principles”

Posted 1 year and 2 months ago

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ANSI/AAMI ST98: A Guideline for Cleaning Validations of Reusable Devices

Posted 1 year and 3 months ago

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FDA Updates the Recognized Consensus Standards Database with New Sterilization Documents

Posted 1 year and 3 months ago

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FDA Publishes Updated Guidance for Breakthrough Devices Program

Posted 1 year and 3 months ago

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FDA Announces Three New Guidances Dedicated to 510(k) Submissions

Posted 1 year and 3 months ago

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Mechanical Hemolysis Assay for Blood Contacting Devices

Posted 1 year and 4 months ago

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FDA Publishes Notice of Modifications to the Recognized Consensus Standards for Medical Devices

Posted 1 year and 5 months ago

5 Steps for A Successful Medical Device Go-To-Market Strategy

Posted 1 year and 5 months ago

Medical Device Commercialization Process: Q&A

Posted 1 year and 5 months ago

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Clinical Trial Cost Analysis with Site Budget Estimates

Posted 1 year and 6 months ago

Your Guide to Biostatistics Outsourcing and Consulting

Posted 1 year and 8 months ago

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AI Guidance for Medical Devices | NAMSA

Posted 1 year and 9 months ago

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U.S. FDA Emergency Use Authorization: CRO Lessons Learned for the MedTech Industry

Posted 1 year and 11 months ago

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Health Canada and FDA eSTAR Pilot

Posted 1 year and 12 months ago

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The Value of Economic Data in Payor Engagement

Posted 2 years ago

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