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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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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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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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Experience innovations of the future
ZEISS QUALITY INNOVATIONS WORLDWIDE event in Oberkochen, Germany, January 20-21, 2026.
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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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Shaping the Future of Metrology – Live in Your Region
Insights into our event series.
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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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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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ZEISS showcases comprehensive workflow for full spectrum of retina care at EURETINA
ZEISS Medical Technology combines its diagnostic, surgical and digital technologies to support healthcare professionals in advancing retinal care.
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ZEISS introduces the new Smartzoom 100
The future of digital microscopy for efficient optical inspections.
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Automated nitrogen analysis reduces costs per sample
N-Realizer analytical system from C. Gerhardt increases productivity with valve block from Festo
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Reduced heat transfer to the media with media-separated valves
In laboratory automation, many liquids are used that react sensitively to heat. One possible factor for the transfer of heat to the fluid are media-separated so...
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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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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Automated nitrogen analysis reduces costs per sample
N-Realizer analytical system from C. Gerhardt increases productivity with valve block from Festo
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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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PMS, Vigilance and Risk Management
Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Un...
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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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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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Speed meets precision for high-density components
ZEISS METROTOM 800 320 kV.
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Improving Nano-Structured Surfaces for Implants with Scanning Electron Microscopy
Promimic, a Swedish company specializing in the development and marketing of nano-structured surfaces for implants, heavily relies on scanning electron microscopes.
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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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Conference recordings now available
Don't miss out on insights from leading experts.
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Clean solutions - Handling viscose substances with precision
Laboratories in the chemical, petrochemical, pharmaceutical and food technology industries are increasingly relying on automation for sample preparation. The Mo...
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