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  • 1.  Stand Alone Software - Start up medical device company - Risk Management Requirements

    Posted 04-Jul-2019 22:08
    Hello All:
    I have a client that is need of advice on the design and implementation of a risk management system compliant with ISO 14971 and 62304, including the delivery of a compliant RMF.  The device is a pre-operative surgical planning tool.  Is there anyone out there who has recent experience in getting CE Mark / TGA Approval / FDA clearance for a similar device.
    I look forward to hearing from you.
    Thanks
    Regards
    Tara  

    Tara M. Creaven-Capasso, RQAP-GLP, RAC

    Director / Founding Partner Caduceus Medical Development, Ltd.

    Member of LifeScience New Zealand (http://lifescience.co.nz/who-we-are/tara-creaven-capasso/)

    New Zealand

    t. +64.21.623005

    e. tcreaven@caduceus-consulting.com

    w. www.caduceusmedicaldevelopment.com

    skype. tara.creaven-capasso

     





  • 2.  RE: Stand Alone Software - Start up medical device company - Risk Management Requirements

    Posted 05-Jul-2019 07:55
    Tara,

    you did did not mention IEC TR 80002-1. This is a guidance document for applying ISO 14971 to software developed under a lifecycle model especially IEC 62304. It is a very useful document for any medical device software.

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

    Original Message


  • 3.  RE: Stand Alone Software - Start up medical device company - Risk Management Requirements

    Posted 05-Jul-2019 09:11
    I do

    ------------------------------
    Eric Henry
    King & Spalding
    Washington DC
    United States
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    Original Message


  • 4.  RE: Stand Alone Software - Start up medical device company - Risk Management Requirements

    This message was posted by a user wishing to remain anonymous
    Posted 07-Jul-2019 13:37
    This message was posted by a user wishing to remain anonymous

    Hi Tara,
    I saw your post and thought I'd send you some information. I have significant experience in this area, especially where software is involved. While I don't have TGA experience, I see that it is very similar to the EU. When it gets to ISO 14971, 62304 and 80001, the design and implementation for a compliant RM system is pretty harmonized.

    I am supplying a 'watered' down ppt presentation on the matter and a current resume. Please let me know if you would like further discussion on this.

    Best regards.
    Don

    Attachment(s)

    pdf
    Peters RiskMgt Overview (brief) 05Jul2019.pdf   1.24 MB 1 version
    pdf
    Resume Don Peters 2018 July.pdf   258 KB 1 version
    Original Message


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