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    Fmea 6 For Medical Devices PDF

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    sbiasoto
    Using dedicated FMEA software like FMEA for Medical Devices can reduce the time spent on Failure Mode and Effects Analysis (FMEA) studies by up to 65% compared to using spreadsheets. It can also decrease the time spent on revisions by up to 45%. Proper FMEA analysis is important for medical device quality improvement, as the FDA reports over 45% of device recalls are due to poor product design. Dedicated FMEA software offers advantages like templates, failure mode libraries, automatic functions, and linking to supporting documents that help users conduct thorough FMEA studies more efficiently.

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    Fmea 6 For Medical Devices PDF

    Uploaded by

    sbiasoto
    492 views2 pages
    Using dedicated FMEA software like FMEA for Medical Devices can reduce the time spent on Failure Mode and Effects Analysis (FMEA) studies by up to 65% compared to using spreadsheets. It can also decrease the time spent on revisions by up to 45%. Proper FMEA analysis is important for medical device quality improvement, as the FDA reports over 45% of device recalls are due to poor product design. Dedicated FMEA software offers advantages like templates, failure mode libraries, automatic functions, and linking to supporting documents that help users conduct thorough FMEA studies more efficiently.

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    FMEA 6 FOR MEDICAL DEVICES.pdf

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    Using dedicated FMEA software like FMEA for Medical Devices can reduce the time spent on Failure Mode and Effects Analysis (FMEA) studies by up to 65% compared to using spreadsheets. It can also decrease the time spent on revisions by up to 45%. Proper FMEA analysis is important for medical device quality improvement, as the FDA reports over 45% of device recalls are due to poor product design. Dedicated FMEA software offers advantages like templates, failure mode libraries, automatic functions, and linking to supporting documents that help users conduct thorough FMEA studies more efficiently.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    492 views2 pages

    Fmea 6 For Medical Devices PDF

    Uploaded by

    sbiasoto
    Using dedicated FMEA software like FMEA for Medical Devices can reduce the time spent on Failure Mode and Effects Analysis (FMEA) studies by up to 65% compared to using spreadsheets. It can also decrease the time spent on revisions by up to 45%. Proper FMEA analysis is important for medical device quality improvement, as the FDA reports over 45% of device recalls are due to poor product design. Dedicated FMEA software offers advantages like templates, failure mode libraries, automatic functions, and linking to supporting documents that help users conduct thorough FMEA studies more efficiently.

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    Protecting People & ProfitabilityTM

    Spreadsheets vs. FMEA For Medical Devices


    Save Time, Energy and Money Time Spent on FMEA Study
    Utilizing the incredible flexibility and power of our dedicated FMEA
    software tool will reduce your analysis time for performing a process or
    design FMEA by as much as 65%. This equates to the software paying for
    Spreadsheet 65
    Time Reduction
    %

    itself after your first study.

    Using FMEA for Medical Devices

    65 %
    Preparation Time
    can reduce the time spent on
    your FMEA analysis by 65%.
    Time Reduction
    Spreadsheet

    45
    Time Spent on Revisions
    %
    Using FMEA for Medical Devices can improve
    your FMEA Study Preparation time by up to 65%. Spreadsheet Time Reduction

    * Statistics based on a Duration vs. Task comparison.


    All information has been gathered through customer
    testimonials and sofware tests. Using FMEA for Medical Devices can reduce
    your FMEA Study revisions time by up to 45%.

    Quality Improvement through FMEA's

    It's estimated that companies will spend as much as 40% of their annual revenue correcting existing quality problems. The FDA recently
    reported that over 45% of all medical device recalls were contributed to poor product design including problems with software and quality.

    Today companies face the dilemma of improving product production without compromising quality. They are willing to spend large sums of
    money and resources to solve this dilemma, even if it involves reverse engineering the product.

    More organizations are now embracing FMEA as a valuable piece of the quality puzzle. FMEA can consider all the factors that contribute to poor
    quality from both design and manufacturing applications. It helps define the appropriate process control plans as well as record and prioritize
    continuous improvements. FMEA is an ongoing process carried out from the conception / design stage throughout the lifetime of the existing
    product. For future products, FMEA provides valuable information to prevent the same mistakes being repeated in new designs.

    "Both Dyadem and their software FMEA for Medical Devices was a major help in the success of our company passing their audit for
    ISO13488. With only days left until the audit was due, your company worked with us to achieve certification and due to the incredible
    capabilities of FMEA for Medical Devices we were able to achieve certification in less than three days"
    Quality Manager - Nova Century Medical

    Phone: 905.882.5055 • E-mail: quality@dyadem.com • Fax: 905.882.5057


    Protecting People & ProfitabilityTM

    WHY CHOOSE FMEA FOR MEDICAL DEVICES? UNSURPASSED POWER


    FMEA for Medical Devices is the most comprehensive and innovative
    Key Features Include:
    software tool for conducting a Failure Modes and Effects Analysis of
    any manufactured medical product. · Pre-formatted industry templates
    · Pre-defined libraries of medical failure modes
    Support of the following standards, regulations and studies: · Create your own libraries from existing FMEA studies

    Design FMEA ISO 13485 APQP FMEA for Medical Devices

    Process FMEA ISO 13488 FDA QSR


    Application FMEA ISO 14971 GMP/CGMP
    Manufacturing FMEA EN Standards
    Software FMEA MIL-STD-1629A
    Service FMEA 510K / Pre-market Notification

    Join companies such as:

    Abbott Labs, Guidant, Motorola, Nova Century, Arthrex Inc., Cook Inc.,
    Tyco Healthcare, Zimmer, Arrow Intl., Baxter, Eli Lilly, Ventracor, Bio-Rad
    Labs, Genzyme, Smith & Nephew, Osteomed Inc, BioMerieux, Medrad
    Inc., Evalve Inc., Medtronic, Boston Scientific, Applied Biosystems,
    Molnlycke Health Care, St. Jude Medical

    · Recommendation management with automatic


    How do spreadsheets compare to our Software? action items

    FMEA for Medical Devices


    FMEA Generic
    Industry Leading Features For Medical Spreadsheet
    Devices Software

    Pre-formatted regulated templates

    Electronic records and signatures

    Mathematical Formulas / Statistics basic

    Automatic 2D and 3D graphing

    Security leveled Data management

    Recommendation manager

    Document Control with SharePoint

    Advanced FMEA Data Check


    · Full document history, revision tracking and audit trails
    Risk criteria checklists (Sev, Occ, Det) · Electronic records and signatures
    · Automatic 2D and 3D graphing
    Linking to supporting documents
    (control plan, flow diagrams, etc.) · Linking to supporting documents, control plans and process
    flow diagrams
    Web-ready HTML PDF reporting basic · Insert supporting documents into any field of your study
    Structured column hierachy · Advanced FMEA Data Check
    basic

    Phone: 905.882.5055 • E-mail: quality@dyadem.com • Fax: 905.882.5057

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