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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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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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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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Discover Precision: Join ZEISS at the Control Fair in Stuttgart
May 6-9, 2025 in Stuttgart. Hall 9, Booth 9309.
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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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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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ZEISS Insights: Measurement of bone plates and screws
Get free access to technical paper.
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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 Top 10 Challenges Facing Laboratories Today
Navigating the Laboratory Automation Landscape
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ZEISS receives FDA clearance for INTRABEAM 700
With its new treatment platform for intraoperative radiotherapy, ZEISS is actively shaping the medical innovation of neuro tumor therapy.
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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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ZEISS supports the transition of spatial biology to clinical research
Slide scanner ZEISS Axioscan 7 spatial biology provides scalable workflow automation.
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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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ZEISS introduces the new Smartzoom 100
The future of digital microscopy for efficient optical inspections.
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Meet us at Control 2025
Innovations that drive efficiency.
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Carl Zeiss Meditec achieves revenue growth and stable operating profit
Further recovery in order entry compared to prior year.
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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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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 at EMO Hannover 2025
Experience some of the most exciting highlights from our ZEISS product portfolio.
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Speed meets precision for high-density components
ZEISS METROTOM 800 320 kV.
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ZEISS Quality Innovations at CONTROL
May 6-9, 2025 in Stuttgart.
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