FDA UDI (DI+PI) FAQ, Sam Lazzara
Notified Body Selection Advice
Notified Bodies are no longer fighting for your attention – you need to fight for their attention!
FDA UDI Implementation in 12 Steps
Here is a high level task list intended for medical device labelers who want to implement FDA requirements for Unique Device Identification. Check out this blog page for general information related to UDI.Continue reading “FDA UDI Implementation in 12 Steps”
EO Batch Release Your Way to Full Validation
I have had several early-stage device company clients who are interested to get to “First In Man” (FIM) clinical use without breaking the bank. My job is to save the client enough money so they can pay my fee and have money left over for other things (like a great Christmas Party).
Continue reading “EO Batch Release Your Way to Full Validation”
Free Labeling
Much can be learned by reading “other Company” medical device labeling and promotional materials
Pyrogenicity – Dead Bugs?
|
I am not a microbiologist but I play one on TV!
|
Independence Matters
Independence is the basis for judicial systems and sporting matches. And for quality systems, it is generally accepted that personnel who are independent of an activity are more objective (impartial) than persons who are directly responsible for the success of the work.
Packaging Validation
Medical device package validation is typically addressed separately from sterile barrier heat seal process validation. Want to save lots of money and time? Continue reading “Packaging Validation”
