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IVDR Reality Check: Are We Moving Fast Enough?
As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...
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Could an overly burdensome QMS be the organization’s own doing?
Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...
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Smooth Flow Pumps – A Milestone in Diaphragm Pump Innovation
From high-resolution printing to life-saving devices, our advanced flow technology delivers smooth, turbulence-free performance where precision is everything.
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New version of ISO 10993-1: the core standard for the biological evaluation of medical devices
ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...
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Membranpumpar – För- och nackdelar
Membranpumpar används i stor utsträckning inom olika industrier tack vare sin tillförlitlighet, mångsidighet och förmåga att hantera gaser och vätskor i medicin...
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Diaphragm Pumps – Pros & Cons
Diaphragm pumps are widely used across industries for their reliability, versatility, and ability to handle gases and liquids in medical, inkjet, analytical, an...
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FDA’s new CSA guidance: transforming software validation for production and quality systems
FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.
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Strategic Clarity: The New Currency in Life Science
In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, ...
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...
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The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
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L&B Medical blir återförsäljare av VELA arbetsstolar och ståstödsstolar
L&B Medical AB blir återförsäljare för VELA medicintekniska arbetsstolar och ståstödsstolar. Serien omfattar ergonomiska arbetsstolar för aktivt sittande med en...
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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...
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Ny studie: Tidewave påskyndar sårläkning utan manuell vändning
L&B Medical AB presenterar ny evidens för Tidewave, madrassen som automatiskt repositionerar patienter. I en ny fallstudie från Gent University Hospital läkte e...
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Safety Data That Makes a Difference – Insights from Safety Manager Ida Björklund
The article highlights safety manager Ida Björklund’s approach to clinical trial safety. She emphasizes that all safety data, no matter how small, must be caref...
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Why Pulmonary Monitoring Devices Rely on KNF Pumps
KNF’s compact, reliable gas diaphragm pumps are essential components of critical pulmonary monitoring devices.
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En tandläkares dagliga rutiner - Sterilt och säkert med vakuum!
Dagens första besök och vakuumpumparna är redan inställda och klara för användning. På tandläkarmottagningen spelar vakuum en viktig roll för att hålla behandli...
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Smooth Flow at High Pressure: KNF Introduces New FP 1.70
The new KNF FP 1.70 combines a multitude of diaphragm pump technology advantages with the benefits of providing a smooth flow with almost no pulsation. Now avai...
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Simplifying IVDR Compliance: Insights from Senior Consultant Emily Malmberg
Navigating the complex demands of the IVDR requires both strategic planning and deep regulatory insight. At GBA Key2Compliance, Senior Consultant Emily Malmberg...
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Why Less is More in Clinical Data – Insights from Senior Clinical Data Manager Åsa Testad
With a background in informatics and programming, Åsa Testad leads clinical data management at GBA Key2Compliance. She ensures that data in clinical studies is ...
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What It Takes to Keep a Clinical Study Going
Clinical Research Associates Ana Zamani and Susanna Hellström play a key role in driving clinical studies forward - not just by monitoring data, but by solving ...
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Membranpumpars avgörande roll i vätgasbränsleceller
I sökandet efter hållbara energilösningar fungerar membranbränslecellspumpar som en nyckelkomponent i vätgashanteringen i bränslecellssystem, vilket ger exakt k...
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Busch Vacuum Solutions lanserar COBRA DH-serien för industriella vakuumapplikationer!
Busch Vacuum Solutions introducerar COBRA DH-serien – en ny generation högpresterande torra skruvvakuumpumpar, särskilt utvecklade för krävande industriella applikationer.
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Nya KNF N 680.15 erbjuder högtrycksprestanda under krävande driftsförhållanden
KNF:s nya N 680.15 är idealisk för högtrycksapplikationer som hanterar vätgas, ädelgaser och andra krävande medier. Den ger ett maximalt tryck på 12 bar (rel.) ...
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