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Medical Device Division (Formerly Biomedical Division)

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    MDD Awards Nomination application
    Schlesinger Grant application
    Medical Device Division Scholarship Application
    CAPA instead of Annual Product Review
    Newsletter Device Feedback March 2023 pdf
    Newsletter Device Feedback March 2023
    Risk Management according to ISO 13485 – impacts of QMSR and TR 24971
    Recording-Planning and Considerations in Setting up Clinical Trials
    Planning and Considerations for Setting up a Clinical Study
    ASQ Medical Device Conference - final
    TCC Secretary
    call for Speakers - MDD Nov 2022
    call-for-Sponsors--MDD Nov 2022_final.pdf
    6Ps_Framework_Design_Reviews Dianna Deeney 06-08-2022
    Design_Reviews_Dianna_Deeney_06-08-2022 Slides
    Adding “Technical” back into Design Reviews 3 Alternatives to Bulleted Slide Deck
    Device Feedback- January -March
    PMS AND PMCF – ALIGNMENT AND DIFFERENCES-20210518 1924-1
    Current FDA enforcement trends for Combination Products and how to Navigate the device aspects of Co
    Combination Products Risk Management-20210512 2214-1
    Division Travel and Check Request
    Line Down_SPC slides 02-16-2022.pdf
    Supplier Process Line Down - Investigation Walkthrough using SPC-20220217 0101-1_Trim.mp4
    Recording of Oct. 13 Webinar CSA Before and After Case Study
    October 13 Webinar CSA Before an After Case Study
    ASQ CSA - MES Implementation - no animation - 22 SEP 2021.pdf
    JOHNSON & JOHNSON Computer Software Assurance -20210923 0004-1.mp4
    Game Changer! Everything about FDA’s Upcoming Guidance on Computer Software Assurance
    Everything you wanted to know about CSA
    Game Changer! Everything about FDA’s Upcoming Guidance on Computer Software Assurance
    Simple, Quick, Practical Alternative to Performing Gage R&R and Specification Guardbanding -20210715 0001-1_Trim.mp4
    Slides for Zorich 2021-07-14 DFW MDDG webinar.pdf
    ISO 9001 Public User Survey Report 2021
    Medical Device Division Annual Meeting June 24 2020
    Proactive Supplier Controls
    Supplier Controls for the Medical Device Industry
    ANSI Commonly Used Acronyms.pdf
    Biomedical Division Intro - 8 Minute VoiceOver.pptx
    2019 Objectives - 11 Jan 2019.docx
    CBA Fact Sheet

    Community Folders

    • Medical Device Division Committee and Member Fol... (1)
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