Notified Bodies are no longer fighting for your attention – you need to fight for their attention!
Continue reading “Notified Body Selection Advice”
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”
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”
Much can be learned by reading “other Company” medical device labeling and promotional materials
Continue reading “Free Labeling”
I am not a microbiologist but I play one on TV!
Continue reading “Pyrogenicity – Dead Bugs?”
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.
Continue reading “Independence Matters”
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”