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The IFU is under FDA auspices and may be technically accurate.
The issue is its composition, which is both deplorable and (I'm sure)
reflects very poorly on the company's image. For example, since when does a
step instruction appear on one page, with the accompanying graphic on the
That's just the beginning. From what I've seen, it's my professional
opinion that the entire thing was drafted by an ESL who didn't understand
the first thing about technical writing. Common English constructs such as
pronouns aren't used. Superfluous capitalization and comma placement is
rampant. Verbosity decreases readability to the point of outright
Each instruction is backwards and is in third-person, passive tense, e.g.,
"If the operator is considering frying Eggs of Chicken variety, they should
select appropriate Frying Pan, in which to fry Eggs."
As a physician, I might get through part of chapter 1 before throwing the
thing down in disgust.
On Thu, Jan 5, 2017 at 10:25 AM, Peter Neilson <neilson -at- windstream -dot- net>
> If this is actually a medical product, as defined by the FDA (and they
> have some weird ideas about what is and is not medical), then the company
> needs to match the FDA spec. Again, my wife is an authority on the subject.
> One fine day she was testing something, and received direction "from above"
> to mark a failure as a pass, on the assumption that she could claim
> ignorance of the test method if they were ever caught having faked it.
> "We're shipping it. Just mark it as good and sign it."
> Well, it was an FDA test, for an FDA-regulated product. Now you've heard a
> lot about the "revolving door" aspect of Federal regulation, how the rules
> are often written by the companies that are regulated. There's a reason for
> that... Sometimes nobody else knows the stuff. The scientist-type people
> who write the rules often really want to have everything scientifically
> correct, in spite of any politics involved. Back and white. No gray, no
> shadows, and no faking.
> She, personally, was the author of the test method. If she got caught
> faking data to get the bad stuff to pass, she, personally, could be liable.
> She had no possibility of claiming ignorance. Couldn't claim, "It wasn't
> marked BAD when I saw it."
> You may be able to hang that particular sword up over the heads of your
> manager's bosses.
> On Thu, 05 Jan 2017 09:33:02 -0500, Chris Morton <salt -dot- morton -at- gmail -dot- com>
> The original IFU was copyrighted in 2013. I've been told that they have
>> product throughout the US, EU and Turkey. Remodeling inside their facility
>> is going on like mad, apparently to accommodate additional hires.
>> So, no, I don't believe the company is in a last-ditch mode to get
>> something to market or a show, per se.
>> Think about this, please, if the IFU is solely regarded as nothing more
>> than a requirement, that they rely instead on individual training (they do
>> have a training facility), then why was I carefully selected to come on?
>> contract is substantial (although I have yet to see the actual PO and be
>> paid anything).
>> Meanwhile, my handler (who I surmise is a newly-minted PM who was directed
>> by higher-ups to "get some help") is out until the 11th to attend to a
>> family matter. I am reticent to approach anyone else within the company,
>> although the person I sense is her boss met with me during my interview
>> we get on quite well.
>> Questions, questions, questions....
>> As the Fab Four sang, *"I gotta feelin'..."*
>> Chris Morton
>> â Substantive Editing â Technical Writing â Proofreading
>> â Marketing Expertise â Mentoring
>> Click to
>> On Wed, Jan 4, 2017 at 4:58 PM, Gene Kim-Eng <techwr -at- genek -dot- com> wrote:
>> I think it's pretty unlikely that the company's management doesn't know
>>> this. So either they don't really care because they've already sussed
>>> they're not going to make it past the angel stage, or they're being
>>> by their investors to get something out to present to potential customers
>>> ASAP. Is there a trade show for that industry coming up in the next
>>> or so?
>>> If their product is going to be FDA regulated, see if you can find
>>> something about document requirements here:
>>> If you can convince them that the FDA is not going *allow* them to ship
>>> product without adequate documentation, that will be much more effective
>>> than trying to pitch image issues to a company that hasn't got one yet.
>>> Gene Kim-Eng
>>> On 1/4/17 3:38 AM, Chris Morton wrote:
>>> I'm looking for some pre-existing verbiage from somewhere that explains
>>> a company's image can be irreparably damaged by publishing and
>>> such junk.
>>> [image: Avast logo]
>>> This email has been checked for viruses by Avast antivirus software.
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