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  • 1.  SaMD Company ISO QMS Software Recommendations

    Posted 06-Feb-2023 14:42
    Edited by Jennifer Wampler 07-Feb-2023 11:56
    Hello, I am currently working for a SaMD startup company. We're looking for an eQMS platform that is suitable for our software medical device needs. Many platforms are heavily geared towards physical product medical devices. Is anyone in SaMD that has any recommendations for a great eQMS? Thanks in advance!

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    Jennifer Wampler
    Regulatory Affairs Associate
    Murrieta CA
    United States
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  • 2.  RE: SaMD Company ISO QMS Software Recommendations

    Posted 07-Feb-2023 03:55
    In terms of eQMS I suggest trying to work with Greenlight Guru.
    They have eQMS for MD Industry.

    From extensive research it appears that they are top.

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    Marian Nicuriuc
    Regulatory Affairs Specialist
    Venlo
    Netherlands
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    Original Message


  • 3.  RE: SaMD Company ISO QMS Software Recommendations

    Posted 07-Feb-2023 09:08
      |   view attached

    Jennifer.

    Have a look at Qualio's eQMS here -seems they are on top SaMD as well as far their eQMS is concerned here---see below:

    https://www.qualio.com/blog/software-as-a-medical-device 

    (* there's a SaMD toolkit referenced on the link above also- not sure how good since I have not checked it myself just yet*)

    I have referred Qualio once before to another RAPs member-they are very pleased with it in general-however that's not to say they're the best on SaMD and compliance within their eQMS offering.

    Suggest you get up to speed also with what the US FDA itself EXPECTS on quality systems with regards to SaMD- so have a look at the attachment we scooped up for you as far as FDA Guidance on our portal smart search that renders full text searching on all PDF Guidance and 21 CFRs with medical devices, biologics and drugs as well.

    We searched on keywords 'SaMD' next to the term 'Quality' or 'QMS' and came up with the US FDA website hosted database  Guidances listed by title on this attachment.

    Let me know if you have more questions- am happy to search further for you or email me at rbalani@estarhelper.com private if you prefer. Note: We found no 21 CFR search hits -FYI-- with the keywords as listed above. Could try more if you let me know.

    Ram B



    ------------------------------
    Ram Balani
    CEO
    FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
    Amawalk , New York
    rbalani@fdasmart.com
    2019130558
    https://tinyurl.com/2wkxp69y
    on US FDA eSTAR for 510(K)
    ------------------------------

    Original Message


  • 4.  RE: SaMD Company ISO QMS Software Recommendations

    Posted 07-Feb-2023 11:58
    Thank you for your recommendation - I will look into it.

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    Jennifer Wampler
    Regulatory Affairs Associate
    Murrieta CA
    United States
    ------------------------------

    Original Message


  • 5.  RE: SaMD Company ISO QMS Software Recommendations

    Posted 07-Feb-2023 11:57
    Thank you for your recommendation - I will look into it.

    ------------------------------
    Jennifer Wampler
    Regulatory Affairs Associate
    Murrieta CA
    United States
    ------------------------------

    Original Message


  • 6.  RE: SaMD Company ISO QMS Software Recommendations

    Posted 08-Feb-2023 09:04

    Jennifer,

    Have you you written your requirements for the software yet?  If you haven't yet done that, you are not ready to review possible candidate software. It is nice to have recommendations, but are they using the software the way you want to use it?

    From my experiences, both good and bad, the time spent developing the requirements has led to good selections vs going in blind leads to poor selections, great expenses, unhappy users, and do overs. 


    Before you go further, spend the time working with a team of potential users and develop the requirements. Just like developing a new medical device, it is time well spent.  


    Next then, you can select potential candidates from the list ( just like selecting suppliers for your device under development) and try them out. Most software suppliers will let you have a trial of the package. You can see what best fits your needs before making a selection. And you can see in advance what you have to configure and where the shortfalls are. Gives you information about how long it will take to install and set up, what resources you will need, and give a better idea of actual cost. 


    As in the old axiom, "if you fail to plan, you plan to fail". This approach allows good planning for your implementation and helps avoid failure. I have been there and done that, believe me, not spending the upfront time required, leads to lower cost and better results. 



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    Edwin Bills MEd, BSc, ASQ Fellow, CQE, CMQ/OE, RAC
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


  • 7.  RE: SaMD Company ISO QMS Software Recommendations

    Posted 07-Feb-2023 09:29
    Hello Jennifer,

    I have following list of identified e-QMS:
    - https://www.qualio.com/blog/medical-device-startup-process
    - https://www.greenlight.guru/
    - https://www.sierralabs.com/
    - https://www.compliancequest.com/
    - https://www.ideagen.com/solutions/quality
    - https://matrixreq.com/
    - https://clarivate.com/products/medtech/
    - https://qt9qms.com/
    - https://www.mastercontrol.com/
    - https://www.etq.com/platform/
    - https://www.qualipro-qms.com/en/
    - https://www.dotcompliance.com/
    - https://www.standardfusion.com/industries/healthcare/
    - https://www.qualtrax.com/industries/other/

    From my first review the only ones simplified/dedicated for SaMD products are:
    - https://scube-technologies.com/
    - https://openregulatory.com/formwork/

    I would be interested in your feedback if you go deeper in your choice.
    Thank you,
    Stephane.

    ------------------------------
    Stephane Berger
    La Ciotat
    France
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    Original Message


  • 8.  RE: SaMD Company ISO QMS Software Recommendations

    Posted 07-Feb-2023 11:59
    Thank you for your recommendations - I will look into it.

    ------------------------------
    Jennifer Wampler
    Regulatory Affairs Associate
    Murrieta CA
    United States
    ------------------------------

    Original Message


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