Cfo swap at cvrx, landry in. The meddevice c-suite carousel spins on, grand
September 25, 2026 at 8:33 AM
Cfo swap at cvrx, landry in. The meddevice c-suite carousel spins on, grand
Donjoy icemna recall: broken connector can stop cold therapy mid-use; if you have one, stop using it and get it checked.
#MedDevice #CAPA #PostMarketSurveillance
#MedDevice #CAPA #PostMarketSurveillance
May 29, 2026 at 9:19 AM
Donjoy icemna recall: broken connector can stop cold therapy mid-use; if you have one, stop using it and get it checked.
#MedDevice #CAPA #PostMarketSurveillance
#MedDevice #CAPA #PostMarketSurveillance
May 7, 2026 at 7:22 PM
#orthopaedic #plastics #nerverepair #tendonrepair #medicaldevice #meddevice #medtech #healthcare
#innovation #surgery #hyaluronicacid
#innovation #surgery #hyaluronicacid
July 7, 2026 at 2:58 PM
Hello worlds!
I am the founding research scientist working to develop a de-novo Class II medical device using focused ultrasound neuromodulation for anxiety at Sanmai.
Can you please help me find more medical device people on Bluesky?
#meddevice #medtech #medical
I am the founding research scientist working to develop a de-novo Class II medical device using focused ultrasound neuromodulation for anxiety at Sanmai.
Can you please help me find more medical device people on Bluesky?
#meddevice #medtech #medical
November 22, 2024 at 6:08 PM
Hello worlds!
I am the founding research scientist working to develop a de-novo Class II medical device using focused ultrasound neuromodulation for anxiety at Sanmai.
Can you please help me find more medical device people on Bluesky?
#meddevice #medtech #medical
I am the founding research scientist working to develop a de-novo Class II medical device using focused ultrasound neuromodulation for anxiety at Sanmai.
Can you please help me find more medical device people on Bluesky?
#meddevice #medtech #medical
T -12 Days. Revolutionize content creation for commercializing Medical Devices.
#MedTech #MedicalDevices #Innovation #RegulatoryAffairs #MedDevice #Entrepreneur #MedicalDevice #Founder #Entrepreneurship
#MedTech #MedicalDevices #Innovation #RegulatoryAffairs #MedDevice #Entrepreneur #MedicalDevice #Founder #Entrepreneurship
August 2, 2026 at 5:24 PM
T -12 Days. Revolutionize content creation for commercializing Medical Devices.
#MedTech #MedicalDevices #Innovation #RegulatoryAffairs #MedDevice #Entrepreneur #MedicalDevice #Founder #Entrepreneurship
#MedTech #MedicalDevices #Innovation #RegulatoryAffairs #MedDevice #Entrepreneur #MedicalDevice #Founder #Entrepreneurship
Notified body counts miss the point, capacity is a network stability problem,, connected workflow, AI-assisted help market access.
#MedDevice #CAPA #Traceability
#MedDevice #CAPA #Traceability
May 8, 2026 at 3:32 AM
Notified body counts miss the point, capacity is a network stability problem,, connected workflow, AI-assisted help market access.
#MedDevice #CAPA #Traceability
#MedDevice #CAPA #Traceability
The Learned Intermediary Doctrine limits manufacturers’ duty to warn consumers directly, focusing responsibility on informed intermediaries like physicians. Exceptions apply for mass immunizations when direct patient warnings are required. #MedDevice #RegulatoryCompliance medmarc.com/life-science...
September 22, 2026 at 4:29 PM
The Learned Intermediary Doctrine limits manufacturers’ duty to warn consumers directly, focusing responsibility on informed intermediaries like physicians. Exceptions apply for mass immunizations when direct patient warnings are required. #MedDevice #RegulatoryCompliance medmarc.com/life-science...
If you're interested in meddevice, medtech world...
Just setting up my blsky.
October 10, 2023 at 2:56 PM
If you're interested in meddevice, medtech world...
Six months into most eQMS implementations, the database wins. The event-driven, AI-routed vision from the demo becomes a structured folder hierarchy with search. Vendors sell transformation, IT delivers taxonomy. #eQMS #CAPA #MedDevice
September 22, 2026 at 8:50 AM
Six months into most eQMS implementations, the database wins. The event-driven, AI-routed vision from the demo becomes a structured folder hierarchy with search. Vendors sell transformation, IT delivers taxonomy. #eQMS #CAPA #MedDevice
to be fair inspectors don't audit slogans; they audit repeat CAPAs, reopened CAPAs with identical root causes expose quality theater.
#ISO13485 #MedDevice #CAPA
#ISO13485 #MedDevice #CAPA
May 8, 2026 at 10:50 AM
to be fair inspectors don't audit slogans; they audit repeat CAPAs, reopened CAPAs with identical root causes expose quality theater.
#ISO13485 #MedDevice #CAPA
#ISO13485 #MedDevice #CAPA
May 26, 2026 at 9:36 PM
twenty years running ISO 9001 sites. Every eQMS I've used pours the engineering into meddevice and leaves 9001 as a checkbox. Genuinely curious what qmsWrapper's 9001 mode actually changes, proper risk thinking or just a template?
September 19, 2026 at 6:27 AM
twenty years running ISO 9001 sites. Every eQMS I've used pours the engineering into meddevice and leaves 9001 as a checkbox. Genuinely curious what qmsWrapper's 9001 mode actually changes, proper risk thinking or just a template?
One device, three regulators, three registries, three vigilance routes - post-Brexit compliance is a non-commutative algebra. Fun.
#MDR #MedDevice #EUDAMED
#MDR #MedDevice #EUDAMED
July 31, 2026 at 4:03 PM
One device, three regulators, three registries, three vigilance routes - post-Brexit compliance is a non-commutative algebra. Fun.
#MDR #MedDevice #EUDAMED
#MDR #MedDevice #EUDAMED
With gundry and swan‑ganz trending, the azurion deaeration‑hose recall proves qms can't rely on paperwork, trace, test, replace affected lots now.
#MedDevice #Traceability #CAPA
#MedDevice #Traceability #CAPA
June 3, 2026 at 4:23 PM
With gundry and swan‑ganz trending, the azurion deaeration‑hose recall proves qms can't rely on paperwork, trace, test, replace affected lots now.
#MedDevice #Traceability #CAPA
#MedDevice #Traceability #CAPA
Y-knotless flex got 510(k). Neat tech, bigger QMS lift: update change-impact mapping, trigger training, tighten traceability. Automated CAPAs/AI-assisted reviewability make audits less wild.
#FDA #MedDevice #CAPA
#FDA #MedDevice #CAPA
June 3, 2026 at 2:22 PM
Y-knotless flex got 510(k). Neat tech, bigger QMS lift: update change-impact mapping, trigger training, tighten traceability. Automated CAPAs/AI-assisted reviewability make audits less wild.
#FDA #MedDevice #CAPA
#FDA #MedDevice #CAPA
🚀 Real-world engineering gets a boost—our surrogate-assisted framework tackles complex design trade-offs efficiently.
First of its kind applied to cardiovascular stents + more.
🧠 Explore the method 👉 asmedigitalcollection.asme.org/mechanicalde...
#EngineeringDesign #Optimization #MedDevice
First of its kind applied to cardiovascular stents + more.
🧠 Explore the method 👉 asmedigitalcollection.asme.org/mechanicalde...
#EngineeringDesign #Optimization #MedDevice
July 30, 2025 at 10:39 PM
🚀 Real-world engineering gets a boost—our surrogate-assisted framework tackles complex design trade-offs efficiently.
First of its kind applied to cardiovascular stents + more.
🧠 Explore the method 👉 asmedigitalcollection.asme.org/mechanicalde...
#EngineeringDesign #Optimization #MedDevice
First of its kind applied to cardiovascular stents + more.
🧠 Explore the method 👉 asmedigitalcollection.asme.org/mechanicalde...
#EngineeringDesign #Optimization #MedDevice
📦 The optimal stent depends on shape & flow. Our review synthesises multi-objective stent geometry optimisation—think haemodynamics meets materials engineering.
Future device makers: this one’s for you! 🔧
www.sciencedirect.com/science/arti...
#StentTech #MedDevice
Future device makers: this one’s for you! 🔧
www.sciencedirect.com/science/arti...
#StentTech #MedDevice
July 9, 2025 at 10:46 AM
📦 The optimal stent depends on shape & flow. Our review synthesises multi-objective stent geometry optimisation—think haemodynamics meets materials engineering.
Future device makers: this one’s for you! 🔧
www.sciencedirect.com/science/arti...
#StentTech #MedDevice
Future device makers: this one’s for you! 🔧
www.sciencedirect.com/science/arti...
#StentTech #MedDevice
Of #AI, the #EU AI Act, and #meddevice ~ Think about #accountability #transparency #bias and #discrimination ....https://www.mddionline.com/artificial-intelligence/what-to-expect-from-the-eu-s-artificial-intelligence-act-in-2025 #healthcare #innovation #fromthemailbag
What to Expect from the EU's Artificial Intelligence Act in 2025
Anne-Gabrielle Haie, a partner with Steptoe LLP, shares what companies can expect from the landmark Artificial Intelligence Act going into 2025.
www.mddionline.com
December 11, 2024 at 8:32 PM
Of #AI, the #EU AI Act, and #meddevice ~ Think about #accountability #transparency #bias and #discrimination ....https://www.mddionline.com/artificial-intelligence/what-to-expect-from-the-eu-s-artificial-intelligence-act-in-2025 #healthcare #innovation #fromthemailbag
folks class II recalls are a QMS wake-up: sterile‑barrier breaches need immediate, locked and notified‑body notification; connected workflow keeps reviews honest, Lipitor approves.
#Traceability #CAPA #MedDevice
#Traceability #CAPA #MedDevice
August 14, 2026 at 3:54 AM
folks class II recalls are a QMS wake-up: sterile‑barrier breaches need immediate, locked and notified‑body notification; connected workflow keeps reviews honest, Lipitor approves.
#Traceability #CAPA #MedDevice
#Traceability #CAPA #MedDevice
Validating AI for GxP: set scope (use+risk). Keep V&V, test data, logs, access control, change-control & training. Expect auditors to ask: who approved, OQ/PQ, traceability, human oversight.
#DesignControls #RiskManagement #MedDevice
#DesignControls #RiskManagement #MedDevice
August 11, 2026 at 7:15 PM
Validating AI for GxP: set scope (use+risk). Keep V&V, test data, logs, access control, change-control & training. Expect auditors to ask: who approved, OQ/PQ, traceability, human oversight.
#DesignControls #RiskManagement #MedDevice
#DesignControls #RiskManagement #MedDevice
ah sure not my strongest area, but feels like a regulatory gap, how do early-stage startups fold dev into a controlled, reviewable QMS? We need connected workflows and reviewable, AI-assisted help, not magic.
#MedDevice #SaMD #eQMS
#MedDevice #SaMD #eQMS
May 2, 2026 at 9:01 AM
ah sure not my strongest area, but feels like a regulatory gap, how do early-stage startups fold dev into a controlled, reviewable QMS? We need connected workflows and reviewable, AI-assisted help, not magic.
#MedDevice #SaMD #eQMS
#MedDevice #SaMD #eQMS
Class II recall (EOPA 22FR) shows pinhole leaks in arterial cannulae during CPB aren't trivial, beyond hypoperfusion risk they reveal and gaps. Do a-driven risk assessment; use connected workflow for rapid supplier action.
#MedDevice #CAPA #Traceability
#MedDevice #CAPA #Traceability
August 16, 2026 at 7:35 AM
Class II recall (EOPA 22FR) shows pinhole leaks in arterial cannulae during CPB aren't trivial, beyond hypoperfusion risk they reveal and gaps. Do a-driven risk assessment; use connected workflow for rapid supplier action.
#MedDevice #CAPA #Traceability
#MedDevice #CAPA #Traceability