by Katrina Rogers | Aug 14, 2018 | Uncategorized
Paper medical records? No way! Standards for the collection, storage, and sharing of data have been important at least since the invention of the printing press in 1440. Just think of how a typical book is organized, with a title page, table of contents, chapters and...
by Katrina Rogers | Aug 12, 2018 | Uncategorized
Difficult but not impossibleAt some point in your pharmaceutical/medical device career, you will likely be part of a company at the receiving end of an agency warning letter. How you respond will determine whether your company survives. Here are a few pointers from...
by Katrina Rogers | Aug 9, 2018 | Uncategorized
It’s how you handle them that matters!The time to prevent inspection observations is before the inspectors arrive! If you aren’t making effective use of your internal audit programs to identify and remediate problems and trends, you should start work to improve them...
by Katrina Rogers | Aug 7, 2018 | Uncategorized
for substantial savings on medical device application fees in FY2019As I mentioned in a previous post, there is a substantial reduction in the user fees for most types of medical device applications for small businesses. Certified small businesses are also eligible...
by Katrina Rogers | Aug 5, 2018 | Uncategorized
The FDA’s CDRH branch posted the 2019 rates and payment procedures for Medical Device User Fees on July 30, 2018. See the table below for a comparison of the 2018 and 2019 fees. Most of these fees are set using a formula that references the standard fee for a...
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