Twenty-four million dollars to former executives. Corporate governance in medtech: lavishly generous on the way out, austere on the way in.

#QualityManagement #MDRCompliance #FDACompliance

to be fair 510(k) clearance is the ante, not the hand. The MAUDE signal trending alongside, 247k imprecise-result reports, is what your PMS-to- loop exists to catch. Under MDR Article 84, this isn't optional. The clearance is decorative if the loop never closes.

#FDACompliance #CAPA #ISO13485

ne behind MAUDE's #4 signal: 73,290 events wiht no device or use problem tagged, the 盲点 (mōten, blind spot) cohort. AI-assisted triage helps only if event context survives for reviewability.

#DataIntegrity #FDACompliance #RegulatoryAffairs

240,800 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/…

#MedTech #FDACompliance #MDRCompliance

My PCP still takes 3 days to tell me flu vs RSV. So yeah, faster respiratory panels clearing FDA = less me spiraling in a waiting room wondering if I need antibiotics. Welcome news 🫠

#MedTech #DesignControl #FDACompliance

New 510(k) cleared today means someone's post-market surveillance process gets its real stress test in 6 months. Hope their complaint handling is ready. 📋

#FDACompliance #CAPA #ISO13485

Urgent Recall: Baby Supplement Undeclared Alcohol – What Brands Must Learn #SupplementRecall #FDACompliance #BrandSafety

Microplastics in Protein: A Growing Concern for Supplement Brands?
#Microplastics #SupplementBrands #FDACompliance

68k events coded "no identified device or use problem." "we don't know" is not a status. Feed unfiltered and your benefit-risk file is a story you're telling yourself.
api.fda.gov/device/event.json?search=date_recei…

#FDACompliance #MedTech #CAPA

READI-Home's decentralised data will test your design-to-PMS links, if they're not there now, home users will find the gaps before FDA does.

#FDACompliance #ISO13485 #DesignControl

Foot surgery quietly becoming the most interesting beat.

#FDACompliance #MDRCompliance #MedTech

SOLTIVE 510(k) cleared. Vigilance obligation starts day one.

#RiskManagement #FDACompliance #ISO13485

Oh good, two regulators writing the same homework assignment. Can't wait to do it twice. 🫠

#MDRCompliance #RegulatoryAffairs #FDACompliance

look new 510(k) clearance for CraniUS Plate, congrats, now the post-market clock starts and the design history file gets the next real inspection.

#DesignControl #FDACompliance #ISO13485

A new 510(k) clearance drops for "PureLift Pro Max", clearance day is the easy part. Year two is where QMS either proves itself or quietly buckles under the first real complaint trend and backlog.

#FDACompliance #MedTech #CAPA

NZ Supplement Exporters Eye US Market: What it Means
#NZSupplements #USMarket #FDACompliance

A patient-specific implant going through 510(k)? My quality brain just sat bolt upright. Want to see that substantial equivalence argument...

#FDACompliance #DesignControl #RegulatoryAffairs

72k MAUDE reports wiht "no problem identified" isn't reassuring, that's post-market capturing noise instead of root causes.
api.fda.gov/device/event.json?search=date_recei…

#MedTech #FDACompliance #CAPA

Endoscopy robot just got fda clearance. "robot" sounds futuristic but the 62304 validation surface just tripled, every motion controller, vision pipeline, failsafe needs evidence. Trend's real, paperwork isn't optional.

#MedTech #ProcessValidation #FDACompliance

Honestly, tamper-evidence is the Part 11 piece I'd actually defend: append-only signature rows even your DBA can't quietly rewrite. Is anyone still running editable audit trails in 2026? (More PMDA-side, but the kihon, the basics, is the same.)

#DataIntegrity #FDACompliance #MedTech