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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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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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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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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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The Future of Metrology is Coming to Your Region
Join our event series.
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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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Quality solutions for medical device R&D applications
From R&D to the quality assurance of series production in medical device manufacturing.
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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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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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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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Sustainability at Festo
On the Way to the Net Zero Era - New Sustainability Report published
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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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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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Join the premier metrology and quality assurance event of the year
ZEISS QUALITY INNOVATION SUMMIT in Berlin, October 22-24, 2024.
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Quality assurance for research and development of medical devices
Overcome the hurdles of research, development, and QA lab environments within the regulated medical technology industry.
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Speed meets precision for high-density components
ZEISS METROTOM 800 320 kV.
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The Top 10 Challenges Facing Laboratories Today
Navigating the Laboratory Automation Landscape
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CT technology for when the inside matters
ZEISS METROTOM 1 now at #HandsOnMetrology.
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Smartzoom 100 – The New Digital Microscope for Maximum Efficiency
Free webinar July 1, 9:00-9:45 AM CEST and 5:00-5:45 PM CEST.
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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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Multiplex immunofluorescence chemistries with ZEISS tissue multiplexing workflow
Bringing leading multiplex immunofluorescence chemistries together in one automated 8-channel imaging platform.
BREAKING