Für #SelteneErkrankungen existieren oft nur einzelne, hochspezialisierte diagnostische #Tests. Damit diese nicht vom Markt verschwinden, begrüßt der VDGH die geplante Reform der #IVDR. #InVitroDiagnostik
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#IVDR
Latest posts tagged with #IVDR on Bluesky
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Posts tagged #IVDR
BioSB develops & produces the most thoroughly validated & #IVDR certified #antibodies for #diagnostics apps such as #immunohistochemistry & #immunofluorescence to detect many #cancer types infectious diseases autoimmunity & other #pathologies
🔗https://www.stratech.co.uk/biosb/immunohistochemistry-2
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#NMI -Expertise beim #Regulatorik -Forum: Bei der 1. Ausgabe der #regularia sind wir dabei und zeigen, wie das Kompetenzzentrum #MIK innovative #KMU unterstützt, die Regularien von Anfang an mitzudenken.
Wir begrüßen Sie gerne am Stand 22!
#Medizintechnik #MDR #IVDR #angewandteForschung
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Cybersecurity in #MedTech is no longer something you "add later."
Under #MDR / #IVDR, security is a prerequisite for market access, not an optional feature.
When addressed too late, the result is rework, delays, or products that never make it to market.
Read more: www.assured.se/areas/medtec...
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Europe’s medical device rules were introduced after safety scandals, but they've proved cumbersome and costly causing shortages. The Commission is proposing course-correction, but might they need a more radical revamp? #MDR #IVDR #MedicalDevices
🔗 www.vitalsigns.news/eu-moves-to-...
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BD Expands BD MAX™ System with New VIASURE Assays to Enhance Diagnostics #USA #Franklin_Lakes #IVDR #BD_MAX™_System #VIASURE
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✨ We’re proud to have #AGES on board, helping us navigate the regulatory landscape and paving the way for trustworthy, future-proof AI-driven imaging technologies.
#AutoPiX #RegulatoryScience #AIinHealthcare #MDR #IVDR #MedicalDevices #DigitalHealth #Innovation #IHI
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🚀 BioSB develops & produces the most thoroughly validated & #IVDR certified #antibodies for #diagnostics app's such as #immunohistochemistry & #immunofluorescence to detect many #cancer types, infectious diseases, autoimmunity & other #pathologies
🔗www.stratech.co.uk/b...
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Delegationsbesuch aus Südostasien heute am #NMI: Forschende des Instituts stellten den Firmenvertreter:innen ihre Arbeit zu #Krebsdiagnostik, an #Biologicals, zu Fragen der Regulierung ( #MDR #IVDR) sowie zu Digitalisierung vor.
#Netzwerken #angewandteForschung
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picture of a one dimensional proton NMR spectrum of human plasma
Good to be up and running plasma samples in 3mm mode within specs again! #nmr #nmrchat #ivdr
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📢#BioSB develops & produces the most thoroughly validated & #IVDR certified #antibodies
for #diagnostics applications:
#immunohistochemistry & #immunofluorescence to detect many #cancer types, infectious diseases, autoimmunity & other #pathologies
🔗tinyurl.com/8w4xwbt8
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#MDR & #IVDR, Sauberkeit von Medizinprodukten und Forschung zu #Wundmonitoring: Dagmar Martin, Kai Fuchsberger & Fabian Körte freuen sich auf spannende Gespräche auf der Swiss Medtech Expo am Gemeinschaftsstand von Medical Mountains.
Kommen Sie gerne vorbei!
#NMI #smte25 #angewandteForschung
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Expertise zusammenzuführen ist das Ziel der Kompetenzzentren am #NMI. Sie bieten Angebote und Forschung, vor allem für #KMU, zu #Biologicals, #Nanoanalytik, Zulassung von #Medizinprodukten und Alternativen zu #Tierversuchen.
#40JahreNMI #NMIGeschichte #Nanoanalytik #MDR #IVDR #3R #NAM #Biologicals
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#NMI auf der Swiss Medtech Expo: In Luzern präsentieren wir unsere Expertise bei #MDR- & #IVDR -Regelungen, Sauberkeit und Wundmonitoring. In einer Keynote stellt zudem Dagmar Martin ein neuartiges Gewebemodell vorbei. Kommen Sie vorbei! Wir freuen uns auf Sie!
#smte25 #angewandteForschung
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Join Martin Schmid, en.co.tec, at #REG25 for an update on #MDR and #IVDR. He explores the tensions between market shakeout and regulatory postponement, and discusses how the medtech industry can – and should – respond to the evolving regulatory landscape.
www.linkedin.com/feed/update/...
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📢 #HealthierEurope. Better access. ESMO welcomes the @ec.europa.eu ’s Life Sciences Strategy - a bold step to reform #IVDR & support clinical innovation. Let’s ensure Europe leads in life sciences & #PatientsCare.
🔗 buff.ly/34j9638
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The European Commission recently wrapped up its public consultation on the #IVDR.
Curious how industry stakeholders responded and what it means for the future of diagnostics in the EU?
Take a closer look into the key takeaways from the consultation - lp.diaceutics.com/latest-ivdr-...
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Have you been keeping up with the latest updates on #IVDR?
Recently, the EU commission ran a public consultation exercise requesting feedback on the IVDR and MDR.
We have provided an in depth analysis of the feedback received which you can access here: lp.diaceutics.com/latest-ivdr-...
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DNV Earns Recognition as Notified Body Under European In Vitro Diagnostic Regulation #Medical_Devices #Norway #Oslo #DNV #IVDR
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Join us for the EuroGentest Online Seminar on April 1, 2025 (1-4 PM CET)!
Get updates on #IVDR, quality assurance, professional recognition & best practices in genetics. Program: buff.ly/5XYNVt8
The webinar is free but registration is mandatory: buff.ly/gCq6ita
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Regulatory ratatouille for labs – What needs to go in the pot?
Our first French language webinar on IVDR, ISO 15189 and Co.
Register: buff.ly/4hOK4ML
#IVDR
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Access the latest #IVDR report along with 2024 updates!
Keep your eyes peeled as we bring you 2025 updates soon 👀
#medsky #oncsky #moleculartesting
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Risk management under #IVDR
How #labs might deliver on a rather tall order
The IVDR has reshaped lab compliance and put out a tall order for labs to serve up. One aspect that proves particularly exasperating is a much stronger emphasis on rigorous risk management.
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Not sure how to begin #IVDR documentation of your in-house tests?
Our interactive wizard will get you started with basic IVDR know-how and then lead you straight to the right strategy for your lab.
Click here: https://buff.ly/4gKEzNF
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Platomics Inks Deals With Sophia Genetics, Agilent for Automated #IVDR Compliance Documentation
via @genomeweb.bsky.social
Read more:
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Our lab solutions also benefit #manufacturers!
#IVDR
EU labs and IVD manufacturers are both subject to strict new IVDR requirements. Labs are now considered the manufacturer of their in-house tests.
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Regulatory ratatouille for labs – What needs to go in the pot?
Our first French language webinar on IVDR, ISO 15189 and Co.
Register: https://buff.ly/3EEPM5l
#IVDR
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As of May 26, 2024, EU labs are to have fulfilled all but one of the IVDR Article 5.5 requirements.
Platomics offers solutions that support labs in fulfilling each lab requirement, enabling a faster and more efficient compliance path.
#IVDR #IVDReady
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Dive deeper into the recent publications:
MDCG 2021-12 Rev.1: FAQs on EMDN
MDCG 2025-1: Ad hoc update procedures
MDCG 2024-2 Rev.1: Annual update procedures
med-di-dia.com/blog/europea...
#MedicalDevices #MedTech #EURegulations #EMDN #Compliance #RegulatoryAffairs #EUDAMED #MDR #IVDR #MedDiDia
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