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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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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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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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Advanced workflow automation and scalable image analysis in spatial biology
ZEISS and Concept Life Sciences announce partnership.
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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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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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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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In-Depth Insights into the Most Useful ZEISS Metrology Expert Tips
Free webinar June 24th, 2025, 9:00-9:45 AM and 5:00-5:45 PM.
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Plug and play lösning för ångfällor
Spirax Sarco har en kompakt "allt-i-ett"-lösning när det kommer till installation av ångfällor. Den kompakta lösningen är optimal eftersom du kan installera kul...
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Quality assurance for research and development of medical devices
Overcome the hurdles of research, development, and QA lab environments within the regulated medical technology industry.
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Explore 3D Testing of Deformation and Motions
Powerful measurement capabilities with the new ZEISS ARAMIS 1.
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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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Flexibelt och skalbart försäkringsskydd för Life Science-bolag
Vi förstår behovet av att minimera kostnader och samtidigt säkerställa ett heltäckande skydd som är anpassat till den komplexa bransch du verkar i. Att ha rätt ...
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Sneak Peek of ZEISS Metrology Expert Tips Season 2
The second season of the video series starts in January 2026, but you can discover more about the highlights of Season 2 now.
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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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DBB ventiler: Snabbare installationer och färre skarvar
Spirax Sarco Safebloc är en lösning med en unik platsbesparande design som innebär snabbare installation och färre skarvar. Spirax
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Reveal the Structures and Functions of Life
Super-resolution microscopes from ZEISS.
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Planerar ni en klinisk studie? Tänk på det här.
Att genomföra en klinisk studie är en komplex och resurskrävande process som kräver noggrann planering och riskhantering. För företag inom life science-sektorn ...
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Quality solutions for medical device R&D applications
From R&D to the quality assurance of series production in medical device manufacturing.
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Advancing Drug Discovery by Combining Complex In-Vitro Models with AI-Powered 3D/4D Image Analysis
Free webinar organized by ZEISS.
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ZEISS unveils AI-powered Research Data Platform
Collaboration with Boehringer Ingelheim champions the future of personalized eye care.
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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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