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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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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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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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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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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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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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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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Press Release
PharmaRelations appoints Niels Buch Leander as new Chief Digital Officer and Executive Vice President Denmark.
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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 Future of Metrology is Coming to Your Region
Join our event series.
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The New Precise Magazine is Available Now
Download the new issue.
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Shaping the Future of Metrology – Live in Your Region
Insights into our event series.
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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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Your solution for right part positioning
ZEISS OmniFix CT - right part positioning solution to get meaningful measuring results for all part sizes.
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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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Discover ZEISS ZEN core – now for electron microscopy
Watch the recording of our free webinar.
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ZEISS unveils AI-powered Research Data Platform
Collaboration with Boehringer Ingelheim champions the future of personalized eye care.
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Scale Up Your Image Analysis
ZEISS arivis Hub for accelerated analysis and faster results.
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ZEISS Connected Quality: One metrology hub
The new product family ZEISS CONNECTED QUALITY is the solution for quick and secure data exchange, quality management and efficient system monitoring.
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New Insights into Microscopy
Watch the recording of our free webinar.
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Unmatched performance and flexibility in its class
The new ZEISS SPECTRUM family is equipped to be the ideal match from measuring small electronics up to larger housings.
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Introducing ZEISS arivis Pro 4.2
ZEISS arivis software enhances custom microscopy image analysis.
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