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

FDA QMSR pulls ISO 13485 in by reference. A tool built only on 820 language means re-mapping procedures the day the rule lands. QmsWrapper covers both. Boring, but that's the quarter you save.

#QualityManagement #FDACompliance #AuditReady

'Patient-specific' 510(k)s are going to expose every QMS that treats design controls as linear. When each device is unique, your DHF isn't a file, it's a branching tree most systems can't draw. 🫠

#DesignControl #FDACompliance #MedicalDeviceQMS

Honestly the fact that OIG had to formally urge a crackdown tells you everything, Medicare Advantage equipment supplier fraud has been the worst kept secret in healthcare for years.

#FDACompliance #ISO13485 #SupplierQuality

New LINQ II 510(k) is the photo op. Trending alongside it: 85k MAUDE reports on imprecise readings. Clearance day is easy. The next decade of work is the actual product.

#FDACompliance #CAPA #MedicalDeviceQMS

www.facebook.com/share/r/19EV...

Schedule H1 drugs require strict compliance and valid prescription. Use these medicines responsibly.

#scheduleh1 #scheduleh1drug #scheduleh1druglist #scheduleh1list #fdacompliance

refluxStop® gets Class III PMA. That's the big leagues. My morning swim feels inadequate by comparison.

#QualityManagement #FDACompliance #TechnicalFile