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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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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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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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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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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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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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Effektivare produktion och minskat spill med turbiditetssensor från OEM Automatic
OEM Automatic erbjuder turbiditetssensorn ITM-51 från Anderson Negele – en lösning som gör det möjligt att effektivisera produktionen samtidigt som både kostnad...
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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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Achieve Effortless, Standardized Automation with the new ZEISS Automation Interface
Simple interfaces for automated loading of CMMs.
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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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Medical Plastics Tips & Tricks
Measuringhero video by ZEISS.
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ZEISS introduces the new Smartzoom 100
The future of digital microscopy for efficient optical inspections.
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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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Final assembly inspection of medical plastics
Technical paper by ZEISS Medical Industry Solutions.
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Speed meets precision for high-density components
ZEISS METROTOM 800 320 kV.
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Meet us at Control 2025
Innovations that drive efficiency.
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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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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...
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Webinar: Automate your processes
Free ZEISS webinar on January 30th, 2025.
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ZEISS Quality Innovations at CONTROL
May 6-9, 2025 in Stuttgart.
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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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Conference recordings now available
Don't miss out on insights from leading experts.
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