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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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Del 2 av Advance serien: Audits och rådgivning
Ingen grön omställning utan en översikt. Audits ger dig exakt de mätvärden och rekommendationer som du behöver för att optimera både verksamheten och koldioxidavtrycket.
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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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Advance: Optimering med mätbart värde från dag ett
Ett flexibelt och holistiskt tillvägagångssätt för optimering av ånganläggningar.
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The Top 10 Challenges Facing Laboratories Today
Navigating the Laboratory Automation Landscape
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Del 3 av Advance serien: Design
Ta reda på hur du kan omvandla en audit till en konkret lösning. Spirax Sarcos designfas ger dig allt du behöver för att implementera ett optimerat och framtids...
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Spirax Sarco - mer än bara ångfällor
Spirax Sarco har under många år levererat ång- och kondensatlösningar till industrin och har genom detta arbete byggt upp en stor kunskap inom design av ånganlä...
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Beställ en audit av ditt ångsystem
Visste du att en av våra bästa tillgångar är vårt erfarna team av servicetekniker? Prata med våra ingenjörer om en audit av ditt system och identifiera förbättr...
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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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How to Assure Quality within R&D Medical Devices
Free webinar on June 3rd, 2025, 9:00 - 9:45 AM CEST and 5:00 - 5:45 PM CEST.
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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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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 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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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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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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Webinar: Can AI replace humans in pharmacovigilance?
The webinar will explore how AI can transform pharmacovigilance by enhancing efficiency, reducing errors, and addressing challenges such as software costs, data...
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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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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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