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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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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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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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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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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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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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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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ZEISS unveils AI-powered Research Data Platform
Collaboration with Boehringer Ingelheim champions the future of personalized eye care.
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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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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Non-destructive testing and assembly control
Assess complete assembly.
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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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Microscope or Measuring Machine? Both!
Watch our demo recording with features, software and best-practices.
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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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The Future of Metrology is Coming to Your Region
Join our event series.
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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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ZEISS introduces the new Smartzoom 100
The future of digital microscopy for efficient optical inspections.
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Quality solutions for medical device R&D applications
From R&D to the quality assurance of series production in medical device manufacturing.
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Effektiv och hygienisk nivåmätning med radar från OEM Automatic
OEM Automatic erbjuder radarnivågivare från Rosemount – en lösning för beröringsfri nivåmätning som kombinerar precision, pålitlighet och lång livslängd. Teknik...
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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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ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment
Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.
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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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Enhance your expertise with your measuring software
Discover the training options in our ZEISS Metrology Portal.
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