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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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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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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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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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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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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 the math just doesn’t add up....
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SGS Fimko beviljas status som anmält organ enligt IVD-förordningen
Helsingfors, 21.10.2025 / SGS Fimko Oy har nått en betydande milstolpe i och med att den Europeiska kommissionen officiellt har utsett företaget till ett anmält...
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Exakt tryckreglering med Tescom – när precision är avgörande
OEM Automatic erbjuder ett brett sortiment av tryckregulatorer från Tescom – anpassade för att möta höga krav inom allt från gasleveranssystem till avancerad in...
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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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Trygg tryckmätning i hygieniska processer – OEM Automatic erbjuder lösningen från WIKA
för just dessa miljöer – modell DMSU21SA med dubbelmembransystem.
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The Future of Metrology is Coming to Your Region
Join our event series.
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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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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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Effektiv och hygienisk nivåmätning med radar från OEM Automatic
OEM Automatic erbjuder radarnivågivare från Rosemount – en lösning för beröringsfri nivåmätning som kombinerar precision, pålitlighet och lång livslängd. Teknik...
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Gasfylld termometer för hygieniska processer
just dessa krävande miljöer.
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Advanced workflow automation and scalable image analysis in spatial biology
ZEISS and Concept Life Sciences announce partnership.
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ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment
Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.
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Multiplex immunofluorescence chemistries with ZEISS tissue multiplexing workflow
Bringing leading multiplex immunofluorescence chemistries together in one automated 8-channel imaging platform.
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Explore our tailored program for Control 2025
Choose an innovation tour, or join our industry-specific guided tours.
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Anpassningsbara vridspjällsventiler från OMAL – lösningen för tuffa miljöer
anpassad efter just dina processer.
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Säker nivåövervakning – vibrationsnivåvakt för krävande processmiljöer
Att kunna detektera nivåer i vätskor med hög tillförlitlighet är avgörande i många industrier – från livsmedelsproduktion till kemikaliehantering. OEM Automatic...
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Optimera processen med OEM Automatics kalibrering och service
För att behålla en driftsäker och effektiv process är det avgörande att mätinstrumenten håller hög precision över tid. OEM Automatic erbjuder därför kompletta l...
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ZEISS continues to drive digital era forward in ophthalmology
2 million digitally planned cataract cases in the U.S. alone.
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