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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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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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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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Sustainability at Festo
On the Way to the Net Zero Era - New Sustainability Report published
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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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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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Optimize Your Visibility
ZEISS presents our newest VersaXRM® 730 3D X-ray microscope.
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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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Discover ZEISS ZEN core – now for electron microscopy
Watch the recording of our free webinar.
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New Insights into Microscopy
Watch the recording of our free webinar.
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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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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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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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Discover Precision: Join ZEISS at the Control Fair in Stuttgart
May 6-9, 2025 in Stuttgart. Hall 9, Booth 9309.
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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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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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Achieve Effortless, Standardized Automation with the new ZEISS Automation Interface
Simple interfaces for automated loading of CMMs.
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Pneumatics Makes a Technological Leap with Piezo
The first high-precision proportional valve terminal VTEP opens up new application areas
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Explore 3D Testing of Deformation and Motions
Powerful measurement capabilities with the new ZEISS ARAMIS 1.
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ZEISS Hosts an exceptional Global Conference on Innovation and Production in Berlin
More than 50 distinguished speakers from leading manufacturing companies.
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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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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.