Twenty-four million dollars to former executives. Corporate governance in medtech: lavishly generous on the way out, austere on the way in.
@regafraid.bsky.social
@regafraid.bsky.socialTwenty-four million dollars to former executives. Corporate governance in medtech: lavishly generous on the way out, austere on the way in.
@qmsnews.bsky.social240,800 MAUDE reports in five months flag "incorrect or imprecise readings." Not a sensor issue. That is a PMS gap, and trend reporting under MDR should have surfaced it before the count hit six figures.
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/…
@regafraid.bsky.socialThe Annex tells you what the brochure won't.
@auditorpaige.bsky.socialFoot surgery quietly becoming the most interesting beat.
@qamia.bsky.socialIIa every 2 yrs, IIb/III annually for PSURs, miss one and your NB can park your CE closeout. Who's got this on a real calendar vs a sticky note? 🫠
@qamia.bsky.socialOh good, two regulators writing the same homework assignment. Can't wait to do it twice. 🫠
@samqadani.bsky.socialIntuitive pushing cardiac robotics into europe via ce mark is genuinely big news. But the constraint nobody puts in the press release is surgeon training throughput. Takes years, not quarters.
@regafraid.bsky.socialQSIT rewards calm preparation. MDR agrees.