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Innehållstyper
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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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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 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 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 Smartzoom 100 for Inspection Efficiency
Catch up on our free webinar.
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Shaping regulatory complexity into strategic clarity
As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data A...
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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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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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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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ZEISS at EMO Hannover 2025
Experience some of the most exciting highlights from our ZEISS product portfolio.
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Discover ZEISS ZEN core – now for electron microscopy
Watch the recording of our free webinar.
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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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Shaping the Future of Metrology – Live in Your Region
Insights into our event series.
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How to avoid measurement inaccuracies due to wear
Expert tip from ZEISS.
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New Insights into Microscopy
Watch the recording of our free webinar.
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How to Assure Quality within R&D Medical Devices
Free webinar on June 3rd, 2025, 9:00 - 9:45 AM CEST and 5:00 - 5:45 PM CEST.
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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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Multiplex immunofluorescence chemistries with ZEISS tissue multiplexing workflow
Bringing leading multiplex immunofluorescence chemistries together in one automated 8-channel imaging platform.
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The Future of Metrology is Coming to Your Region
Join our event series.
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Sustainability at Festo
On the Way to the Net Zero Era - New Sustainability Report published
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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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Enhance your expertise with your measuring software
Discover the training options in our ZEISS Metrology Portal.
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