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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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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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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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Shaping the Future of Metrology – Live in Your Region
Insights into our event series.
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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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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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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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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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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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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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Organize and Manage Digital Classrooms
Create engaging lessons with ZEISS Labscope Teacher.
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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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ZEISS at EMO Hannover 2025
Experience some of the most exciting highlights from our ZEISS product portfolio.
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Discover ZEISS ZEN core – now for electron microscopy
Watch the recording of our free webinar.
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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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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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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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Revealing the secrets of a part
CT inspection in automation technology at Festo.
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Explore our tailored program for Control 2025
Choose an innovation tour, or join our industry-specific guided tours.
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New Insights into Microscopy
Watch the recording of our free webinar.
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100 years of Festo
The spirit of invention is deeply rooted in our corporate culture. Since our foundation, we have been setting benchmarks by developing innovative solutions that...
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