Blog Posts with Tag: QSR

Relationships Really Do Matter
How you manage your partners is one of the first things an auditor looks for
Tuesday, September 07, 2010
LDT: Legal Distinction Terminated
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 2010
More Than One Best Way
There isn't a single way to design documentation or procedures.
Monday, November 23, 2009
What is a "Regulatory Affair" and should I have one?
Perhaps we have more in common with a fiery mistress or hunky boy toy than we might suspect.
Monday, July 13, 2009
Designed for (Future) Success
The consequences of a poorly developed IVD product go well beyond a few negative postings in a blog.
Wednesday, June 10, 2009
A PMA Is Not the Kiss of Death
The amount of work you need to do for a PMA is not very much larger than the amount you are supposed to do for a 510(k).
Monday, April 27, 2009
Tips 9 & 10
Manufacturing before trials, Focus
Friday, March 13, 2009
Tips 5 & 6
Teamwork, education
Wednesday, March 11, 2009
Tips 3 & 4
Prompt QSR, listening to FDA
Tuesday, March 10, 2009
Tips 1 & 2
Business planning, starting with design control
Monday, March 09, 2009
TBD or Not TBD
Ten tips to avoid common documentation errors.
Thursday, February 26, 2009
Creating Value in Difficult Times
How do you build value while you're cutting budgets?
Wednesday, November 12, 2008
Specimen Preparation Systems: Insider Info
What happens when you joke about starting a blog.
Friday, August 15, 2008

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