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Regulatory Affairs

Home » Topics » Medical Devices » Regulatory Affairs
  • January 31, 2023

    FDA Issues Final Guidance on SLA Lasers

  • January 30, 2023

    New Mentoring Opportunity Available Through Pediatric Device Consortia Grants Program

    The FDA has invited devicemakers to apply for funding to develop medical devices for children through the FDA’s Pediatric Device Consortia grants program.

  • January 30, 2023

    FDA Analysis of Global UDI Database Shows Increasing Submissions

    The database has almost doubled in size since 2019.

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  • January 30, 2023

    CardioRenal Systems’ RenalGuard Therapy Gets Breakthrough Nod

  • January 27, 2023

    Correction: Medtronic Updates HeartWare Ventricular Assist Device Battery Recall

  • January 27, 2023

    FDA Analysis of Global UDI Database Shows Increasing Submissions

  • January 27, 2023

    FDA Labels Datascope/Getinge, Emergent Device Recalls as Class 1

  • January 26, 2023

    IceCure Tumor-Freezing Pump Receives Patent Nod

  • January 25, 2023

    Califf Says Wearable Sensors Must Be Part of Restructuring of Evidence Generation

  • January 25, 2023

    Medtronic Updates HeartWare Ventricular Assist Device Battery Recall

  • January 24, 2023

    AdvaMed Defends Ethylene Oxide Sterilization

  • January 24, 2023

    DePuy Pays $9.75 Million in Anti-Kickback Settlement

  • January 24, 2023

    Califf Says Wearable Sensors Must Be Part of Restructuring of Evidence Generation

Read More

Products

  • International standards for clinical trials 500

    International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

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  • Eric henry christopher gates blue500

    Medical Device Cybersecurity: The Regulatory Landscape and How to Defend Your Practices During an Inspection – Webinar Recording/Transcript

    $287.00
  • Davidlchesney aqua500

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success – Webinar Recording/Transcript

    $287.00
  • Schniepp steven seyed michael matthew green

    Manufacturing Quality: Using Audit Observations to Predict Problems – Webinar Recording/Transcript

    $387.00
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Events

  • 01Feb

    The Future of QMS: Will the Recent Announcement and Delays Have a Global Impact?

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

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