FDA Compliance

Filters

Components of Effective Clinical Trial Management

Posted 2 months ago

FDA’s Regulation of AI/ML SaMD

Posted 3 months ago

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Comparing US FDA vs EU MDR Medical Device Software Requirements

Posted 5 months ago

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FDA Releases “Transparency of Machine Learning – Enabled Medical Devices: Guiding Principles”

Posted 6 months ago

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An In-Depth Exploration of Reimbursement Billing Guides and Their Benefits

Posted 7 months ago

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Preclinical Studies for Dental Bone Graft Devices – 510(k) Submissions

Posted 7 months ago

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Collection of Race and Ethnicity Data in Clinical Studies – Standardizing the Sociocultural Construct of Our Society

Posted 9 months ago

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Will Vaporized Hydrogen Peroxide (VHP) Sterilization for Medical Devices Become More Common?

Posted 10 months ago

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Industry Update: Quality Management System Regulation (QMSR)

Posted 10 months ago

ASCA Accreditation: FDA Annual Report and NAMSA Customer Experience

Posted 10 months ago

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Embracing Digital Health Technologies: FDA’s New Guidance for Clinical Trials

Posted 11 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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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 4 months ago

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

Posted 1 year and 4 months ago

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Mechanical Hemolysis Assay for Blood Contacting Devices

Posted 1 year and 4 months ago

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