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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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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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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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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 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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Plug and play dräneringslösningar
En universalkoppling är en anordning som du placerar i din rörledning, och som ger dig friheten att enkelt och snabbt renovera och byta ut ångfällor. Detta mins...
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The Future of Metrology is Coming to Your Region
Join our event series.
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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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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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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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ZEISS showcases expansion of ophthalmic care options creating industry-leading workflow solutions
ZEISS Medical Technology will showcase new ophthalmic innovations and market milestones at ESCRS 2025 in Copenhagen.
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Sustainability at Festo
On the Way to the Net Zero Era - New Sustainability Report published
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ZEISS showcases comprehensive workflow for full spectrum of retina care at EURETINA
ZEISS Medical Technology combines its diagnostic, surgical and digital technologies to support healthcare professionals in advancing retinal care.
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Shaping the Future of Metrology – Live in Your Region
Insights into our event series.
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Improving Nano-Structured Surfaces for Implants with Scanning Electron Microscopy
Promimic, a Swedish company specializing in the development and marketing of nano-structured surfaces for implants, heavily relies on scanning electron microscopes.
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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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One System, Three Contrasting Techniques
ZEISS Axioscan 7 clinical - your digital slide scanner for diagnostics and clinical research.
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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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Advanced workflow automation and scalable image analysis in spatial biology
ZEISS and Concept Life Sciences announce partnership.
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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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Discover the new ZEISS Axioscan 7 clinical
Your digital slide scanner for diagnostics & clinical research.
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Speed meets precision for high-density components
ZEISS METROTOM 800 320 kV.
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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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