Regulatory Open Forum

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  • 1.  Technical Writing Question

    Posted 20-Aug-2016 16:42

    I do a lot of technical writing (webinars, seminars, workshops, etc.) and have a question about the more effective way to write examples.

    It seems to me there are two methods, using pronouns and using (made up) names.

    In the first case (pronoun based), I might say:

    A doctor diagnoses a patient with Type II diabetes; the doctor asks the patient to check her blood glucose each day. The doctor prescribes a starter kit with a four different devices: a blood glucose meter, a device to “fire” the lancet, a package of lancets, and a package of blood glucose test strips.

    In the second case (personalized case), I might say:

    Dr. Amita Gupta diagnoses her patient, Emily O’Conner with Type II diabetes; Dr. Gupta asks Ms O’Conner to check her blood glucose each day. Dr. Gupta prescribes a starter kit with a four different devices: a blood glucose meter, a device to “fire” the lancet, a package of lancets, and a package of blood glucose test strips.

    I do this kind of thing so often, that I’m immune to the differences. However, a lot of literature uses the more personalized example type. In particular, IRS guidance documents seem to be particularly good at personal examples, small worksheets, etc.

    Is there a standard that describes the best approach? If not, is there a documented best practice for which you could provide a reference?

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    Dan O'Leary
    Swanzey NH
    United States
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  • 2.  RE: Technical Writing Question

    Posted 20-Aug-2016 22:27
    Dan,

    To be more appealing to the audience, I suppose we could/would use examples to be more realistic and on points for training/education and/or awareness purposes. 

    For this, I use customized examples, to the similar extent, what FDA uses as manifested in FDA guidances, rules, WLs, EIRs, etc.  I also try to use some examples based on complaints (liability or under FCAs) filed by firms, patients, etc. 

    In other words, I have tried to customize examples to reflect real world scenarios/events/incidents on a needed basis. 

    This has been my general practices.  

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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  • 3.  RE: Technical Writing Question

    Posted 28-Aug-2016 02:01

    Who are you training?  People in the medical device industry?  Healthcare professionals?  University students?

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com