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Archives for October 2018

New FDA Guidelines Affecting Your Medical Device Development

Bob Marshall Sings “The Regulatory Blues”
(You’ll want to hear this.)

I had a pre-submission meeting
so I went down to Silver Springs.
I took documents, and drawings,
and lots of other things.
They said, “Go home, boy.
Wait until the telephone rings.”

I got the Regulatory Blues.
About to lose my mind.
I’m waiting on some data
no one can seem to find.
Now my 510(k) submission
is running three months behind.

I got a call last week.
Said they were coming for an inspection.
Someone down at the hospital
got a real bad infection.
Now they’re telling me
I got to recall the whole collection.

Tried to renew my registration.
I just sent it in the mail.
Because every time I went online,
their website would fail.
Now they’re putting me in handcuffs,
and taking me to jail…

Click here for the slides and transcript. »

How Product Design, Technology and Manufacturing Change on Miniaturized Medical Devices

Click here for the slides and transcript. »