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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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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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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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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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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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FAQ: Hjälper ni startups med försäkring?
Gallagher erbjuder specialiserad försäkring och riskhantering för alla typer av företag inom Life Science. Vi finns med från tidig startup längs med vägen mot i...
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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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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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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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Experience innovations of the future
ZEISS QUALITY INNOVATIONS WORLDWIDE event in Oberkochen, Germany, January 20-21, 2026.
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PharmaRelations appoints new Chief Digital Officer and Executive VP Denmark
Press Release
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ZEISS Smartzoom 100 for Inspection Efficiency
Catch up on our free webinar.
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Shaping the Future of Metrology – Live in Your Region
Insights into our event series.
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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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In-Depth Insights into the Most Useful ZEISS Metrology Expert Tips
Free webinar June 24th, 2025, 9:00-9:45 AM and 5:00-5:45 PM.
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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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Automated nitrogen analysis reduces costs per sample
N-Realizer analytical system from C. Gerhardt increases productivity with valve block from Festo
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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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ZEISS introduces the new Smartzoom 100
The future of digital microscopy for efficient optical inspections.
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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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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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The Future of Metrology is Coming to Your Region
Join our event series.
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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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