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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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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
, it may signal what’s ahead for medical devices.
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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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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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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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Vad utmärker de tillverkare som lyckats med en snabb MDR-certifiering?
Övergången till MDR har generellt inneburit längre handläggningstider i Europa för CE-märkning av medicintekniska produkter. En MDR-certifieringsprocess omfatta...
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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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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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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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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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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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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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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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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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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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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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Advanced workflow automation and scalable image analysis in spatial biology
ZEISS and Concept Life Sciences announce partnership.
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PharmaRelations appoints new Chief Digital Officer and Executive VP Denmark
Press Release
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The New Precise Magazine is Available Now
Download the new issue.
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Digitaliseringen förändrar vårt sätt att arbeta med ånga
Moderna ångsystem utsätts för större påfrestningar än någonsin tidigare, och även små avvikelser kan få stora konsekvenser för driften. Detta ställer helt nya k...
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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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