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#ISO13485

21
posts · 30d
13
users
1
posts / day
1.6
posts / user
-33% vs last week

#ISO13485 is an active hashtag on Bluesky. In the last 30 days, 13 people shared 21 posts with it — around 1 a day. Activity is down 33% versus the previous week, peaking on Jul 13 with 2 posts.

#ISO13485 posts per day (last 30 days)

Related tags

Tags most often used together with #ISO13485.

#MedTech 13 #qmsWrapper 12 #QMS 8 #MedDevice 7 #MDR 7 #IVDR 7 #Traceability 6 #QualityManagement 6 #ISO14971 5 #AIinQMS 5 #FDA 5 #CAPA 5

Posts with #ISO13485

@marcusreedhf.bsky.social
about 12 hours ago
honestly i ain't an expert, but audits should measure the health‑supportive‑environment metrics that study offers, resource distribution, management gaps, tech use, not just tick a SOP box. #ISO13485 #RiskManagement #MedDevice
0 0 0
Sarah O'Brien
@qmssarah78.bsky.social
1 day ago
After harmonization, 820 and ISO 13485 largely converge on risk, traceability and electronic signatures, so we focus on reviewability and migration plans. #ISO13485 #FDA #QMS
0 0 0
Thomas Brenner
@regafraid.bsky.social
3 months ago
to be fair inspectors don't audit slogans; they audit repeat CAPAs, reopened CAPAs with identical root causes expose quality theater. #ISO13485 #MedDevice #CAPA
0 0 2
Ashraf Ismail
@theashrafismail.bsky.social
4 months ago
Quality is a Standard, Not a Border crossing. ⚓ Foreign origin is a logistics risk, not a guarantee of safety. MDMSA has mastered ISO 13485 as our indigenous standard. Choose zero compromise. Choose MDMSA Manufacturers. #ISO13485 #MDMSA #SouthAfrica #TechSovereignty #Iran
A close-up, high-definition photograph of a precision-engineered stainless steel medical valve component. A polished, reflective gold medallion is set into the center. The embossed black text on the gold reads, in concentric circles: 'MDMSA SOVEREIGN CERTIFIED'. Below this, text on the steel reads: 'ISO 13485 COMPLIANT: FLUENTLY SPOKEN'. A subtle bright blue lens flare emanates from the center, giving a high-tech feel. At the bottom, text reads 'LOCAL MANUFACTURING, WORLD CLASS STANDARDS, ZERO COMPROMISE!', alongside the MDMSA logo.
0 0 1
Andreas Scherer
@andreasscherer.bsky.social
over 1 year ago
We have just wrapped up a dynamic 2024. Please read my blog for more details on our strategy for the new year. Here’s to an outstanding 2025! #GoldenHelix #ClinicalGenomics #PrecisionMedicine #Cancer #Pharmacogenomics #BYOC #NGS #ISO13485 #CEMark www.goldenhelix.com/blog/….
Golden Helix: Charting Our 2025 Strategy

www.goldenhelix.com

Golden Helix: Charting Our 2025 Strategy

We just wrapped up a dynamic and rewarding 2024. Hence, we want to take a moment to celebrate key milestones that have set the stage for our next chapter. This year, we pushed our solutions to new fro...
0 1 1
Thomas Brenner
@regafraid.bsky.social
about 1 month ago
nationwide CRC test rollout raises QMS obligations: kepe Validation Report proof, run continuous performance monitoring, track supplier KPIs, and use a connected, reviewable QMS so-driven risk mitigation is timely and traceable. #ISO13485 #RegulatoryAffairs #CAPA
medical device QMS
0 0 2
@aoifecardiac.bsky.social
9 days ago
QMSR narrows gaps between 21 CFR Part 820 and ISO 13485, easier to harmonise docs. Yeah no, US still has inspection/reporting quirks, so keep your‑specific workflows in place. #PatientSafety #ISO13485 #FDA
0 0 0
pulse check
@pulsercheck.bsky.social
10 days ago
regs miss a 'battery buffer' for updates. Treat releases like BESS: deterministic baseline + rollback guarentees. Startups need validtaed QMS (qmsWrapper). High bp = heart works harder #RegulatoryAffairs #SaMD #ISO13485
0 0 0

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