Regulatory Open Forum

  • 1.  RE:Risk-Based Biocompatiblity Assessment Timeframes?

    Posted 19-Apr-2014 13:33
    I'm afraid I didn't ask my question very clearly, for which I apologize.  For people with experience with ISO 10993 risk-based biocompatiblity assessment with new devices, I would like to know about how much PROJECT time it takes to get from:

    Time Point A - You have manufactured devices ready for testing
    to:
    Time Point B - The tox risk assessment of the results of the chemical characterization/quantification of degradation products has been completed.

    I am asking for the purposes of project planning.  I came to this forum because a regulatory professionals is often a member of a new product development team, one who tends to pay close attention to the biocompatibility validation.  The biocompatibility and toxicology experts are typically external to the product development team and are often external to the company.  Therefore, regulatory professionals are likely to be in a position to know how long it took a project to get from A to B, where bio/tox experts are not,

    As an example, I was planning to give my tox assessment consultant a week to turn around the risk assessment, but that's not project time, that just the consultant's turnaround time.  Project time is something quite different.  If you have been part of a project team through the design V&V phase, you know what I mean.  And if you have, then I would be very grateful to know of your experience with this part of it.

    Thanks.

    -------------------------------------------
    Julie Omohundro RAC
    Durham NC
    United States
    -------------------------------------------





    -------------------------------------------
    Julie Omohundro RAC
    Durham NC
    United States
    -------------------------------------------






    Original Message