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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 later approved. While this “radical transparency” currently applies only to pharmaceuticals...
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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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Explore our tailored program for Control 2025
Choose an innovation tour, or join our industry-specific guided tours.
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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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The FDA’s new transparency policy (Part 3)
test data. It necessitates strategic foresight, sound regulatory judgment, and a thorough understanding of the Agency’s evolving expectations.
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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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The Future of Metrology is Coming to Your Region
Join our event series.
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New version of ISO 10993-1: the core standard for the biological evaluation of medical devices
. The standard was approved and is now under publication.
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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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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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Explore the possibilities of the new ZEISS METROTOM 800 320 kV
Free ZEISS webinar July 10, 9:00-9:45 AM and 5:00-5:45 PM.
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Introducing ZEISS arivis Pro 4.2
ZEISS arivis software enhances custom microscopy image analysis.
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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Webinar: Support Trial Patients Transitioning to the Commercial Space
Register for expert insights on supporting Phase III clinical trial patients post-approval and read our blog on advanced Patient Assistance Programs.
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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 ZEISS ZEN core – now for electron microscopy
Watch the recording of our free webinar.
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ZEISS Smartzoom 100 for Inspection Efficiency
Catch up on our free webinar.
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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 security, and regulatory...
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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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New Insights into Microscopy
Watch the recording of our free webinar.
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The Top 10 Challenges Facing Laboratories Today
Navigating the Laboratory Automation Landscape
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Conference recordings now available
Don't miss out on insights from leading experts.
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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 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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